Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes.

BACKGROUND: African Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME) has been less effective at improving glycemic control for African Americans. Our objective was to determine whether a novel, culturally tailored DSME intervention would result in sustained improvements in glycemic control in low-income African-American patients of public hospital clinics. RESEARCH DESIGN AND METHODS: This randomized controlled trial (n = 211) compared changes in hemoglobin A1c (A1c) at 6, 12, and 18 months between two arms: (1) Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes. Cluster-adjusted ANCOVA modeling was used to assess A1c changes from baseline to 6, 12, and 18 months, respectively, between arms. RESULTS: At 6 months, A1c decreased significantly more in the intervention group than the control group (- 0.76 vs - 0.21%, p = 0.03). However, by 12 and 18 months, the difference was no longer significant (12 months - 0.63 intervention vs - 0.45 control, p = 0.52). There was a decrease in A1c over 18 months in both the intervention (ß = - 0.026, p = 0.003) and the comparison arm (ß = - 0.018, p = 0.048) but no difference in trend (p = 0.472) between arms. The intervention group had greater improvements in nutrition knowledge (11.1 vs 6.0 point change, p = 0.002) and diet quality (4.0 vs - 0.5 point change, p = 0.018) while the comparison group had more participants with improved medication adherence (24% vs 10%, p < 0.05) at 12 months. CONCLUSIONS: The LIFE intervention resulted in improved nutrition knowledge and diet quality and the comparison intervention resulted in improved medication adherence. LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months. NIH TRIAL REGISTRY NUMBER: NCT01901952.

Design of a bilevel clinical trial targeting adherence in heart failure patients and their providers: The Congestive Heart Failure Adherence Redesign Trial (CHART).

BACKGROUND: Socioeconomically disadvantaged patients are at an increased risk for adverse heart failure (HF) outcomes based upon nonadherence to medications and diet. Physicians are also suboptimally adherent to prescribing evidence-based therapy for HF. METHODS: Congestive Heart Failure Adherence Redesign Trial (CHART) (NCT01698242) is a multicenter, bilevel, cluster randomized behavioral efficacy trial designed to assess the impact of intervening simultaneously on physicians and their socioeconomically disadvantaged patients (annual income <$30,000) having HF with reduced ejection fraction. Treatment arm physicians received individualized feedback on their adherence to prescribing evidence-based therapy. Their patients received weekly home visits from community health workers aimed at promoting understanding of HF and integrating adherence into daily life. Control arm physicians received regular updates on advances in HF management, and patients received monthly HF educational tip sheets produced by the American Heart Association. The primary outcome was all-cause hospital days over 30 months. RESULTS: A total of 72 physicians (treatment, 35; control, 37) and their 320 patients (treatment, 157; control, 163) were recruited within 2 years. Randomization of physicians with all of their patients being assigned to the same arm was feasible and did not compromise the comparability of patients by arm. Using 5 recruiting hospitals located within disadvantaged neighborhoods produced a cohort that was primarily African American and representative of low-income urban patients with HF with reduced ejection fraction. CONCLUSION: CHART will determine the value of intervening on low adherence simultaneously in physicians and their socioeconomically disadvantaged patients in reducing all-cause hospitalization days.

Higher Stroke Risk with Lower Blood Pressure in Hemodynamic Vertebrobasilar Disease: Analysis from the VERiTAS Study.

BACKGROUND: Despite concerns regarding hypoperfusion in patients with large-artery occlusive disease, strict blood pressure (BP) control has become adopted as a safe strategy for risk reduction of stroke. We examined the relationship between BP control, blood flow, and risk of subsequent stroke in the prospective Vertebrobasilar Flow Evaluation and Risk of Transient Ischemic Attack and Stroke (VERiTAS) study. METHODS: The VERiTAS study enrolled patients with recent vertebrobasilar (VB) transient ischemic attack or stroke and ≥50% atherosclerotic stenosis or occlusion of vertebral or basilar arteries. Hemodynamic status was designated as low or normal based on quantitative magnetic resonance angiography. Patients underwent standard medical management and follow-up for primary outcome event of VB territory stroke. Mean BP during follow-up (<140/90 versus ≥140/90 mm Hg) and flow status were examined relative to subsequent stroke risk using Cox proportional hazards analysis. RESULTS: The 72 subjects had an average of 3.8 ± 1.2 BP recordings over 20 ± 8 months of follow-up; 39 (54%) had mean BP of<140/90 mm Hg. The BP groups were largely comparable for baseline demographics, risk factors, and stenosis severity. Comparing subgroups stratified by BP and hemodynamic status, we found that patients with both low flow and BP <140/90 mm Hg (n = 10) had the highest risk of subsequent stroke, with hazard ratio of 4.5 (confidence interval 1.3-16.0, P = .02), compared with the other subgroups combined. CONCLUSIONS: Among a subgroup of patients with VB disease and low flow, strict BP control (BP <140/90) may increase the risk of subsequent stroke.

Hemodynamic Features of Symptomatic Vertebrobasilar Disease.

BACKGROUND AND PURPOSE: Atherosclerotic vertebrobasilar disease is an important cause of posterior circulation stroke. To examine the role of hemodynamic compromise, a prospective multicenter study, Vertebrobasilar Flow Evaluation and Risk of Transient Ischemic Attack and Stroke (VERiTAS), was conducted. Here, we report clinical features and vessel flow measurements from the study cohort. METHODS: Patients with recent vertebrobasilar transient ischemic attack or stroke and ≥50% atherosclerotic stenosis or occlusion in vertebral or basilar arteries (BA) were enrolled. Large-vessel flow in the vertebrobasilar territory was assessed using quantitative MRA. RESULTS: The cohort (n=72; 44% women) had a mean age of 65.6 years; 72% presented with ischemic stroke. Hypertension (93%) and hyperlipidemia (81%) were the most prevalent vascular risk factors. BA flows correlated negatively with percentage stenosis in the affected vessel and positively to the minimal diameter at the stenosis site (P<0.01). A relative threshold effect was evident, with flows dropping most significantly with ≥80% stenosis/occlusion (P<0.05). Tandem disease involving the BA and either/both vertebral arteries had the greatest negative impact on immediate downstream flow in the BA (43 mL/min versus 71 mL/min; P=0.01). Distal flow status assessment, based on an algorithm incorporating collateral flow by examining distal vessels (BA and posterior cerebral arteries), correlated neither with multifocality of disease nor with severity of the maximal stenosis. CONCLUSIONS: Flow in stenotic posterior circulation vessels correlates with residual diameter and drops significantly with tandem disease. However, distal flow status, incorporating collateral capacity, is not well predicted by the severity or location of the disease.

Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association.

The aim of this updated guideline is to provide comprehensive and timely evidence-based recommendations on the prevention of future stroke among survivors of ischemic stroke or transient ischemic attack. The guideline is addressed to all clinicians who manage secondary prevention for these patients. Evidence-based recommendations are provided for control of risk factors, intervention for vascular obstruction, antithrombotic therapy for cardioembolism, and antiplatelet therapy for noncardioembolic stroke. Recommendations are also provided for the prevention of recurrent stroke in a variety of specific circumstances, including aortic arch atherosclerosis, arterial dissection, patent foramen ovale, hyperhomocysteinemia, hypercoagulable states, antiphospholipid antibody syndrome, sickle cell disease, cerebral venous sinus thrombosis, and pregnancy. Special sections address use of antithrombotic and anticoagulation therapy after an intracranial hemorrhage and implementation of guidelines.

Factors associated with levels of adherence to inhaled corticosteroids in minority adolescents with asthma.

BACKGROUND: Nonadherence to inhaled corticosteroids (ICS) is a significant risk factor for poor asthma outcomes in minority adolescents with persistent asthma. OBJECTIVE: To identify factors associated with nonadherence to daily ICS in this target population. METHODS: Adolescents 11 to 16 years old, self-identified as African American or Hispanic, diagnosed with persistent asthma and with an active prescription for daily ICS were invited to participate. Participant adherence to ICS was electronically measured during 14 days. Concurrently, participants completed the following assessments: demographic information, asthma history, asthma control, asthma exacerbations, media use, depression, asthma knowledge, ICS knowledge, and ICS self-efficacy. Of the 93 subjects, 68 had low (<48%) adherence and 25 had high (>48%) adherence. RESULTS: Older age and low ICS knowledge each were associated with low (≤48%) adherence (P < .01 for the 2 variables). CONCLUSION: Older age and low ICS knowledge each may be associated with poor adherence to ICS in minority adolescents with persistent asthma. Although older age often is associated with the assignment of increased responsibility for medication-taking behavior, it may not be associated with increased adherence. Continued and expanded efforts at promoting asthma education and specifically knowledge of ICS may increase adherence to ICS.

Does self-management counseling in patients with heart failure improve quality of life? Findings from the Heart Failure Adherence and Retention Trial (HART).

PURPOSE: Heart failure (HF) is associated with poor health-related quality of life (HRQOL). The purpose of our study is to determine the effect of a self-management intervention on HRQOL domains across time, overall, and in prespecified demographic, clinical, and psychosocial subgroups of HF patients. METHODS: HART was a single-center, multi-hospital randomized trial. Patients (n = 902) were randomized either to a self-management intervention with provision of HF educational information or an enhanced education control group which received the same HF educational materials. HRQOL was measured by the Quality of Life Index, Cardiac Version, modified, and the Medical Outcomes Study 36-item Short-Form Health Survey physical functioning scale. Analyses included descriptive statistics and mixed-effects regression models. RESULTS: In general, overall, study participants' HRQOL improved over time. However, no significant differences in HRQOL domain were detected between treatment groups at baseline or across time (p > 0.05). Subgroup analyses demonstrated no differences by treatment arm for change in HRQOL from baseline to 3 years later. CONCLUSIONS: We conclude that in our cohort of patients, the self-management intervention had no benefit over enhanced education in improving domains of HRQOL and HRQOL for specified HF subgroups.

A self-management intervention for African Americans with comorbid diabetes and hypertension: a pilot randomized controlled trial.

INTRODUCTION: The objective of this pilot 6-month randomized controlled trial was to determine the effectiveness of an intensive, community-based, group intervention that focused on diet, physical activity, and peer support for reducing weight among urban-dwelling African Americans with comorbid type 2 diabetes and hypertension. METHODS: Sixty-one participants were randomized into an intervention or control group. The 6-month intervention consisted of 18 group sessions led by a dietitian in a community setting and weekly telephone calls from a peer supporter. The intervention featured culturally tailored nutrition education, behavioral skills training, and social support focused on changes to diet and physical activity. The control group consisted of two 3-hour group sessions of diabetes self-management education taught by a community health worker. Outcome measures were assessed at baseline and 6 months. The primary outcome was achievement of a 5% weight reduction at 6 months. A secondary outcome was achievement of a 0.5 percentage-point reduction in hemoglobin A1c (HbA1c). RESULTS: Groups did not differ in achievement of the weight-loss goal. Intervention participants lost a mean of 2.8 kg (P = .01); control participants did not lose a significant amount of weight. A greater proportion of intervention (50.0%) than control (21.4%) participants reduced HbA1c by 0.5 percentage points or more at 6 months (P = .03). CONCLUSION: The intervention was more effective than usual care (short-term diabetes education) at improving glycemic control, but not weight, in low-income African Americans with comorbid diabetes and hypertension. A community-based 6-month group class with culturally tailored education, behavioral skills training, and peer support can lead to a clinically significant reduction in HbA1c.

Evaluation of the Fight Asthma Now (FAN) program to improve asthma knowledge in urban youth and teenagers.

BACKGROUND: School-based asthma education programs targeting disadvantaged youth and teens with asthma are lacking. OBJECTIVES: To assess the impact of the Fight Asthma Now (FAN) educational program among 2 populations of predominantly low-income minority students: youth (3(rd)-6(th) graders) and teens (7(th)-8(th) graders). METHODS: Chicago-area elementary schools were invited to participate in this stratified 2-arm study. Eligible schools were assigned to participate either in the intervention or in the control arm. Within each participating school, eligible students were recruited and grouped (stratified by grade and age) to form teen or youth classes. Participants completed a pre- and post-intervention asthma knowledge questionnaire and observation for spacer technique competency. The treatment group received the FAN curriculum between the evaluations. RESULTS: A sample of 26 low-income, predominantly minority-serving schools was recruited. Most participating schools were randomized in a 3:1 ratio to form 25 youth classes (19 intervention and 6 control group) and 16 teen classes (11 intervention and 5 control group), resulting in 275 vs 69 youth and 141 vs 51 teens in the intervention and control groups, respectively. Stratified analyses were performed, and clustering within the school and class was taken into consideration in analyses. Multilevel models adjusting for school, class, ethnicity, sex, and pretest score indicate that the FAN intervention significantly increased both knowledge and spacer competency test scores, among both the youth and teen participants (P = .011 with respect to knowledge score among teen students, P < .0001 for all other cases). CONCLUSIONS: This study suggests that FAN significantly increases asthma knowledge and spacer technique competency within this high-risk population.

Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial.

CONTEXT: Motivating patients with heart failure to adhere to medical advice has not translated into clinical benefit, but past trials have had methodological limitations. OBJECTIVE: To determine the value of self-management counseling plus heart failure education, compared with heart failure education alone, for the primary end point of death or heart failure hospitalization. DESIGN, SETTING, AND PATIENTS: The Heart Failure Adherence and Retention Trial (HART), a single-center, multiple-hospital, partially blinded behavioral efficacy randomized controlled trial involving 902 patients with mild to moderate heart failure and reduced or preserved systolic function, randomized from the Chicago metropolitan area between October 2001 and October 2004 and undergoing follow-up for 2 to 3 subsequent years. INTERVENTIONS: All patients were offered 18 contacts and 18 heart failure educational tip sheets during the course of 1 year. Patients randomized to the education group received tip sheets in the mail and telephone calls to check comprehension. Patients randomized to the self-management group received tip sheets in groups and were taught self-management skills to implement the advice. MAIN OUTCOME MEASURE: Death or heart failure hospitalization during a median of 2.56 years of follow-up. RESULTS: Patients were representative of typical clinical populations (mean age, 63.6 years; 47% women, 40% racial/ethnic minority, 52% with annual family income less than $30,000, and 23% with preserved systolic function). The rate of the primary end point in the self-management group was no different from that in the education group (163 [40.1%)] vs 171 [41.2%], respectively; odds ratio, 0.95 [95% confidence interval, 0.72-1.26]). There were no significant differences on any secondary end points, including death, heart failure hospitalization, all-cause hospitalization, or quality of life. CONCLUSIONS: Compared with an enhanced educational intervention alone, the addition of self-management counseling did not reduce death or heart failure hospitalization in patients with mild to moderate heart failure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00018005.

Technology Assisted Behavior Intervention to Extend Sleep Among Adults With Short Sleep Duration and Prehypertension/Stage 1 Hypertension: A Randomized Pilot Feasibility Study.

STUDY OBJECTIVES: Short sleep duration contributes to hypertension, yet few behavioral sleep extension interventions have been developed. The goal of our study was to evaluate the feasibility and preliminary efficacy of a technology assisted sleep extension intervention among individuals with prehypertension/stage 1 hypertension on sleep, blood pressure and patient reported outcomes. METHODS: Adults aged 30-65 with 24h ambulatory blood pressure (ABP) > 120/80 mmHg and average weekday sleep duration < 7 h/night were randomized 2:1 to a 6-week technology assisted intervention versus a self-management control group. The intervention included a wearable sleep tracker, smartphone application, weekly didactic lessons and brief telephone coaching. The control group was instructed to maintain their current sleep schedule. Data were analyzed using descriptive statistics and nonparametric statistics to evaluate differences in between groups as well as prepost changes within each group. We also conducted bivariate correlations to evaluate predictors of change in sleep and ABP. RESULTS: A total of 16 adults were randomized into the study (11 intervention, 5 control group, 8 women, mean age 45.8 years, standard deviation 9.8 years.) Results at 6-week follow-up demonstrated greater improvement in the intervention group for total sleep time (P = .027), reductions in 24-hour systolic blood pressure (P = .013) and diastolic blood pressure (P = .026), improvements in sleep disturbance (P = .003) and sleep-related impairment (P = .008). Participants in the intervention group completed 90% of the coaching sessions and rated the enjoyment of the intervention as 4 or 5 out of 5. CONCLUSIONS: Technology assisted sleep extension intervention is feasible and well liked in this population. Results demonstrate the potential for this intervention to improve sleep duration, quality and 24-hour ABP.

BRIGHTEN Heart intervention for depression in minority older adults: Randomized controlled trial.

OBJECTIVE: Assess the effectiveness of an interdisciplinary geriatric team intervention in decreasing symptoms of depression among urban minority older adults in primary care. Secondary outcomes included cardiometabolic syndrome and trauma. METHOD: 250 African American and Hispanic older adults with PHQ-9 scores ≥ 8 and BMI ≥ 25 were recruited from 6 underserved urban primary care clinics. Intervention arm participants received the BRIGHTEN Heart team intervention plus membership in Generations, an older adult educational activity program; comparison participants received only Generations. RESULTS: Both arms demonstrated clinically significant improvements in PHQ-9 scores at 6 months (-5 points, intervention and comparison) and 12 months (-7 points intervention, -6.5 points comparison); there was no significant difference in change scores between groups on depression or cardiometabolic syndrome at 6 months; there was a small difference in depression trajectory at 12 months (p < .001). More participants in the treatment group (70.7%) had greater than 50% reduction in PHQ-9 scores than the comparison group (56.3%; p = .036). For those with higher PTSD symptoms (PCL-C6), improvement in depression was significantly better in the intervention arm than the comparison arm, regardless of baseline PHQ-9 (p = .001). In mixed models, those with higher PTSD symptoms (ß = -0.012, p = < 0.001) in the intervention arm showed greater depression improvement than those with lower PTSD symptoms (ß = -0.004, p = .001). CONCLUSIONS: The BRIGHTEN Heart intervention may be effective in reducing depression for urban minority older adults. Further research on team care interventions and screening for PTSD symptoms in primary care is warranted. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

The Heart Failure Adherence and Retention Trial (HART): design and rationale.

BACKGROUND: Heart failure (HF) is increasing in prevalence and is associated with prolonged morbidity, repeat hospitalizations, and high costs. Drug therapies and lifestyle changes can reduce hospitalizations, but nonadherence is high, ranging from 30% to 80%. There is an urgent need to identify cost-effective ways to improve adherence and reduce hospitalizations. TRIAL DESIGN: The Heart Failure Adherence and Retention Trial (HART) evaluated the benefit of patient self-management (SM) skills training in combination with HF education, over HF education alone, on the composite end points of death/HF hospitalizations and death/all-cause hospitalizations in patients with mild to moderate systolic or diastolic dysfunction. Secondary end points included progression of HF, quality of life, adherence to drug and lifestyle regimens, and psychosocial function. The HART cohort was composed of 902 patients including 47% women, 40% minorities, and 23% with diastolic dysfunction. After a baseline examination, patients were randomized to SM or education control, received 18 treatment contacts over 1 year, annual follow-ups, and 3-month phone calls to assess primary end points. Self-management treatment was conducted in small groups and aimed to activate the patient to implement HF education through training in problem-solving and 5 SM skills. The education control received HF education in the mail followed by a phone call to check comprehension. CONCLUSIONS: The significance of HART lies in its ability to determine the clinical value of activating the patient to collaborate in his or her care. Support for the trial hypotheses would encourage interdisciplinary HF treatment, drawing on an evidence base not only from medicine but also from behavioral medicine.

Elements of nonpharmacologic interventions that prevent progression of heart failure: a meta-analysis.

This review examined whether nonpharmacologic treatment was associated with reductions in all-cause mortality and heart failure (HF) hospitalizations and investigated the effects of face-to-face contact and longer treatment duration on these outcomes. MEDLINE and PsycINFO databases were searched through June 2006 and bibliographies of potential articles were hand-searched. Nonpharmacologic treatment was associated with significantly lower odds of HF hospitalizations (odds ratio [OR], 0.41; 95% confidence interval [CI], 0.30-0.56) and death (OR, 0.69; 95% CI, 0.56-0.85) compared with control treatment. Face-to-face contact was associated with significantly lower odds of HF hospitalization (OR, 0.42; 95% CI, 0.22-0.81; P<.05) and death (OR, 0.63; 95% CI, 0.44-0.91; P<.05) as compared with control treatment. Longer treatment duration (>or=12 months) was associated with a 65% reduction in the rate of HF hospitalizations and a 36% reduction in death rate. Nonpharmacologic treatment featuring face-to-face contact is particularly effective in reducing HF hospitalization and all-cause mortality rates.

Posttraumatic stress and depression: potential pathways to disease burden among heart failure patients.

BACKGROUND AND OBJECTIVES: Posttraumatic stress disorder (PTSD) and Major Depressive Disorder (MDD) are associated with high disease burden. Pathways by which PTSD and MDD contribute to disease burden are not understood. DESIGN: Path analysis was used to examine pathways between PTSD symptoms, MDD symptoms, and disease burden among 251 low-income heart failure patients. METHODS: In Model 1, we explored the independent relationship between PTSD and MDD symptoms on disease burden. In Model 2, we examined the association of PTSD symptoms and disease burden on MDD symptoms. We also examined indirect associations of PTSD symptoms on MDD symptoms, mediated by disease burden, and of PTSD symptoms on disease burden mediated by MDD symptoms. RESULTS: Disease burden correlated with PTSD symptoms (r = .41; p < .001) and MDD symptoms (r = .43; p < .001) symptoms. Both models fit the data well and displayed comparable fit. MDD symptoms did not mediate the association of PTSD symptoms with disease burden. Disease burden did mediate the relationship between PTSD symptoms and MDD symptoms. CONCLUSIONS: Results support the importance of detection of PTSD in individuals with disease. Results also provide preliminary models for testing longitudinal data in future studies.

Multilevel Interventions To Address Health Disparities Show Promise In Improving Population Health.

Multilevel interventions are those that affect at least two levels of influence-for example, the patient and the health care provider. They can be experimental designs or natural experiments caused by changes in policy, such as the implementation of the Affordable Care Act or local policies. Measuring the effects of multilevel interventions is challenging, because they allow for interaction among levels, and the impact of each intervention must be assessed and translated into practice. We discuss how two projects from the National Institutes of Health's Centers for Population Health and Health Disparities used multilevel interventions to reduce health disparities. The interventions, which focused on the uptake of the human papillomavirus vaccine and community-level dietary change, had mixed results. The design and implementation of multilevel interventions are facilitated by input from the community, and more advanced methods and measures are needed to evaluate the impact of the various levels and components of such interventions.

Impact of Dietary Sodium Restriction on Heart Failure Outcomes.

OBJECTIVES: This study sought to evaluate the impact of sodium restriction on heart failure (HF) outcomes. BACKGROUND: Although sodium restriction is advised for patients with HF, data on sodium restriction and HF outcomes are inconsistent. METHODS: We analyzed data from the multihospital HF Adherence and Retention Trial, which enrolled 902 New York Heart Association functional class II/III HF patients and followed them up for a median of 36 months. Sodium intake was serially assessed by a food frequency questionnaire. Based on the mean daily sodium intake prior to the first event of death or HF hospitalization, patients were classified into sodium restricted (<2,500 mg/d) and unrestricted (≥2,500 mg/d) groups. Study groups were propensity score matched according to plausible baseline confounders. The primary outcome was a composite of death or HF hospitalization. The secondary outcomes were cardiac death and HF hospitalization. RESULTS: Sodium intake data were available for 833 subjects (145 sodium restricted, 688 sodium unrestricted), of whom 260 were propensity matched into sodium restricted (n = 130) and sodium unrestricted (n = 130) groups. Sodium restriction was associated with significantly higher risk of death or HF hospitalization (42.3% vs. 26.2%; hazard ratio [HR]: 1.85; 95% confidence interval [CI]: 1.21 to 2.84; p = 0.004), derived from an increase in the rate of HF hospitalization (32.3% vs. 20.0%; HR: 1.82; 95% CI: 1.11 to 2.96; p = 0.015) and a nonsignificant increase in the rate of cardiac death (HR: 1.62; 95% CI: 0.70 to 3.73; p = 0.257) and all-cause mortality (p = 0.074). Exploratory subgroup analyses suggested that sodium restriction was associated with increased risk of death or HF hospitalization in patients not receiving angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (HR: 5.78; 95% CI: 1.93 to 17.27; p = 0.002). CONCLUSIONS: In symptomatic patients with chronic HF, sodium restriction may have a detrimental impact on outcome. A randomized clinical trial is needed to definitively address the role of sodium restriction in HF management. (A Self-management Intervention for Mild to Moderate Heart Failure [HART]; NCT00018005).

Traumatic stress and cardiopulmonary disease burden among low-income, urban heart failure patients.

BACKGROUND: Traumatic events and posttraumatic stress disorder (PTSD) are associated with increased risk for cardiopulmonary disease (CPD) in veterans, men, and primarily White populations. Less is known about trauma, PTSD, and CPD burden among low-income, racial minority residents who are at elevated risk for trauma and PTSD. It was hypothesized that traumatic events and PTSD would be significantly associated with CPD burden among low-income, racial minority residents. METHODS: We evaluated cross-sectional relationships between traumatic events, PTSD, depression, and CPD burden in 251 low-income, urban, primarily Black adults diagnosed with heart failure. Data were analyzed using bivariate analyses, logistic and linear regression. RESULTS: Forty-three percent endorsed at least one traumatic event. Twenty-one percent endorsed two or more traumatic events. In logistic regression analyses, traumatic events were associated with increased prevalence of coronary artery disease (adjusted odds=1.33, p<.05), hypertension (adjusted odds=1.28, p<.05), chronic obstructive pulmonary disease (adjusted odds=1.52, p<.01), and cardiac arrest (adjusted odds=1.27, p<.05). PTSD was also related to increased risk for chronic obstructive pulmonary disease (adjusted odds=1.22, p<.05) and was associated with earlier onset of heart failure (ß=-.13, p<.05). LIMITATIONS: The study utilizes cross-sectional, self-report data. CONCLUSIONS: Findings support the link between traumatic events, PTSD, and CPD burden in low-income, primarily Black patients with heart failure. Depression appears to be less closely linked to CPD burden, despite receiving significant attention in the literature. The accumulation of traumatic events may exacerbate CPD burden among urban, low-income, racial minority residents with heart failure; findings highlight the importance of PTSD screening.

Impact of Physical Inactivity on Mortality in Patients With Heart Failure.

The impact of physical inactivity on heart failure (HF) mortality is unclear. We analyzed data from the HF Adherence and Retention Trial (HART) which enrolled 902 patients with New York Heart Association class II/III HF, with preserved or reduced ejection fraction, who were followed for 36 months. On the basis of mean self-reported weekly exercise duration, patients were classified into inactive (0 min/week) and active (≥1 min/week) groups and then propensity score matched according to 34 baseline covariates in 1:2 ratio. Sedentary activity was determined according to self-reported daily television screen time (<2, 2 to 4, >4 h/day). The primary outcome was all-cause death. Secondary outcomes were cardiac death and HF hospitalization. There were 196 inactive patients, of whom 171 were propensity matched to 342 active patients. Physical inactivity was associated with greater risk of all-cause death (hazard ratio [HR] 2.01, confidence interval [CI] 1.47 to 3.00; p <0.001) and cardiac death (HR 2.01, CI 1.28 to 3.17; p = 0.002) but no significant difference in HF hospitalization (p = 0.548). Modest exercise (1 to 89 min/week) was associated with a significant reduction in the rate of death (p = 0.003) and cardiac death (p = 0.050). Independent of exercise duration and baseline covariates, television screen time (>4 vs <2 h/day) was associated with all-cause death (HR 1.65, CI 1.10 to 2.48; p = 0.016; incremental chi-square = 6.05; p = 0.049). In conclusion, in patients with symptomatic chronic HF, physical inactivity is associated with higher all-cause and cardiac mortality. Failure to exercise and television screen time are additive in their effects on mortality. Even modest exercise was associated with survival benefit.

Effect of Hemodynamics on Stroke Risk in Symptomatic Atherosclerotic Vertebrobasilar Occlusive Disease.

IMPORTANCE: Atherosclerotic vertebrobasilar (VB) occlusive disease is a significant etiology of posterior circulation stroke, with regional hypoperfusion as an important potential contributor to stroke risk. OBJECTIVE: To test the hypothesis that, among patients with symptomatic VB stenosis or occlusion, those with distal blood flow compromise as measured by large-vessel quantitative magnetic resonance angiography (QMRA) are at higher risk of subsequent posterior circulation stroke. DESIGN, SETTING, AND PARTICIPANTS: A prospective, blinded, longitudinal cohort study was conducted at 5 academic hospital-based centers in the United States and Canada; 82 patients from inpatient and outpatient settings were enrolled. Participants with recent VB transient ischemic attack or stroke and 50% or more atherosclerotic stenosis or occlusion in vertebral and/or basilar arteries underwent large-vessel flow measurement in the VB territory using QMRA. Physicians performing follow-up assessments were blinded to QMRA flow status. Follow-up included monthly telephone calls for 12 months and biannual clinical visits (for a minimum of 12 months, and up to 24 months or the final visit). Enrollment took place from July 1, 2008, to July 31, 2013, with study completion on June 30, 2014; data analysis was performed from October 1, 2014, to April 10, 2015. EXPOSURE: Standard medical management of stroke risk factors. MAIN OUTCOMES AND MEASURES: The primary outcome was VB-territory stroke. RESULTS: Of the 82 enrolled patients, 72 remained eligible after central review of their angiograms. Sixty-nine of 72 patients completed the minimum 12-month follow-up; median follow-up was 23 (interquartile range, 14-25) months. Distal flow status was low in 18 of the 72 participants (25%) included in the analysis and was significantly associated with risk for a subsequent VB stroke (P = .04), with 12- and 24-month event-free survival rates of 78% and 70%, respectively, in the low-flow group vs 96% and 87%, respectively, in the normal-flow group. The hazard ratio, adjusted for age and stroke risk factors, in the low distal flow status group was 11.55 (95% CI, 1.88-71.00; P = .008). Medical risk factor management at 6-month intervals was similar between patients with low and normal distal flow. Distal flow status remained significantly associated with risk even when controlling for the degree of stenosis and location. CONCLUSIONS AND RELEVANCE: Distal flow status determined using a noninvasive and practical imaging tool is robustly associated with risk for subsequent stroke in patients with symptomatic atherosclerotic VB occlusive disease. Identification of high-risk patients has important implications for future investigation of more aggressive interventional or medical therapies.