Does Vitamin D Provide Added Benefit to Antihypertensive Therapy in Reducing Left Ventricular Hypertrophy Determined by Cardiac Magnetic Resonance?

BACKGROUND: Left ventricular hypertrophy (LVH) and vitamin D deficiency have been linked to hypertension (HTN) and cardiovascular disease, particularly in African Americans (AAs). Our objective was to determine if the addition of vitamin D to antihypertensive therapy would lead to greater regression of LV mass index (LVMI) as determined by cardiac magnetic resonance (CMR) after 1 year in vitamin D deficient AA patients with uncontrolled HTN and LVH. METHODS: This study was a randomized, double-blind, placebo-controlled, single-center study. AA patients with HTN (systolic blood pressure [BP] >160 mm Hg), increased LVMI, and vitamin D deficiency (<20 ng/ml) were randomized. All patients received antihypertensive therapy combined with biweekly 50,000 IU vitamin D3 (vitamin D group, n = 55) or placebo (placebo group, n = 58). RESULTS: At 1 year, there were no statistical differences between the vitamin D and placebo groups in LVMI (-14.1 ± 14.6 vs. -16.9 ± 13.1 g/m2; P = 0.34) or systolic BP (-25.6 ± 32.1 vs. -25.7 ± 25.6 mm Hg; P = 0.99) reduction, respectively. Serum vitamin D levels increased significantly in the vitamin D group compared with placebo (12.7 ± 2.0 vs. 1.8 ± 8.2 ng/ml; P < 0.001). CONCLUSIONS: In this high-risk cohort of AAs we did not find an association between vitamin D supplementation and differential regression of LVMI or reduction in systolic BP. However, our study suffered from a small sample size with low statistical power precluding a definitive conclusion on the therapeutic benefit of vitamin D in such patients. CLINICAL TRIALS REGISTRATION: Trial Number NCT01360476. Full trial protocol is available from corresponding author.

Angiotensin-converting enzyme inhibitors increase anti-fibrotic biomarkers in African Americans with left ventricular hypertrophy.

Angiotensin-converting enzyme inhibitors (ACEi) are part of the indicated treatment in hypertensive African Americans. ACEi have blood pressure-independent effects that may make them preferred for certain patients. We aimed to evaluate the impact of ACEi on anti-fibrotic biomarkers in African American hypertensive patients with left ventricular hypertrophy (LVH). We conducted a post hoc analysis of a randomized controlled trial in which hypertensive African American patients with LVH and vitamin D deficiency were randomized to receive intensive antihypertensive therapy plus vitamin D supplementation or placebo. We selected patients who had detectable lisinopril (lisinopril group) in plasma using liquid-chromatography/mass spectrometry analysis and compared them to subjects who did not (comparison group) at the one-year follow-up. The pro-fibrotic marker type 1 procollagen C-terminal propeptide (PICP) and the anti-fibrotic markers matrix metalloproteinase-1 (MMP-1), tissue inhibitor of metalloproteinases 1 (TIMP-1), telopeptide of collagen type I (CITP), and N-acetyl-seryl-aspartyl-lysyl-proline (Ac-SDKP) peptide were measured. Sixty-six patients were included, and the mean age was 46.2 ± 8 years. No difference was observed in the number and intensity of antihypertensive medications prescribed in each group. Patients with detectable lisinopril had lower blood pressure than those in the comparison group. The anti-fibrotic markers Ac-SDKP, MMP-1, and MMP-1/TIMP-1 ratio were higher in patients with detectable ACEi (all p < .05). In a model adjusted for systolic blood pressure, MMP-1/TIMP-1 (p = .02) and Ac-SDKP (p < .001) levels were associated with lisinopril. We conclude that ACEi increase anti-fibrotic biomarkers in hypertensive African Americans with LVH, suggesting that they may offer added benefit over other agents in such patients.

Efficacy of enhanced emergency department discharge for chronic hypertension management - Results of a randomized controlled trial.

INTRODUCTION: AchieveBP is a randomized controlled trial (RCT) of an education intervention for patients with chronic hypertension who have uncontrolled blood pressure (BP) at discharge from an urban emergency department (ED). The study examined efficacy and moderators of an educational intervention in an RCT on BP control at 180-day post-intervention. METHODS: Participants were recruited from a single, urban ED and randomized to receive or not to receive hypertension education. To minimize potential bias, participants were all started on an evidence-based anti-hypertensive regimen and medications were dispensed directly to participants by the study team. Bivariate analysis was performed to examine differences in sociodemographic characteristics between patients achieving BP control and those who did not. Paired t-test was used to compare the difference of systolic and diastolic BP between baseline and 180 days post-discharge. Multiple logistic regression analysis examined interaction of covariates and intervention on achieving BP control. RESULTS: One hundred and thirty-nine participants were randomized into the study. All were African-American with a mean age of 47.6 (SD = 10.8) years; 51% were male, 63% had smoked cigarettes and 15% had diabetes. A total of 66 patients completed the study (47.4%), 44 of whom (67%) achieved BP control. However, there was no difference in BP reduction or control between the two groups. Age and smoking status showed moderation effects on intervention efficacy. CONCLUSION: Despite a neutral effect of our intervention, a high level of BP control was achieved overall, suggesting that the ED may be a viable location for efforts aimed at reducing the impact of chronic hypertension in predominantly African American communities.

Improving Blood Pressure Among African Americans With Hypertension Using a Mobile Health Approach (the MI-BP App): Protocol for a Randomized Controlled Trial.

BACKGROUND: African Americans shoulder significant disparities related to hypertension (HTN), which is a serious public health problem in the city of Detroit, Michigan, where more than 80% of the population is African American. Connectivity through smartphones, use of home blood pressure (BP) monitoring, and newly developed mobile health (mHealth) interventions can facilitate behavioral changes and may improve long-term self-care for chronic conditions, but implementation of a combined approach utilizing these methods has not been tested among African American patients with uncontrolled HTN. Since African Americans are more likely than other racial or ethnic subgroups to utilize the emergency department (ED) for ambulatory care, this presents an opportunity to intervene on a population that is otherwise difficult to reach. OBJECTIVE: The MI-BP app aims to reduce health disparities related to HTN in the community by employing a user-centered intervention focused on self-BP monitoring, physical activity, reduced sodium intake, and medication adherence. We seek to test the efficacy of MI-BP, an mHealth app for HTN self-management, on BP control (primary aim), physical activity, sodium intake, and medication adherence (secondary aim) in African Americans with HTN. This study also seeks to evaluate the cost-effectiveness of MI-BP when compared with usual care methods. METHODS: This is a 1-year randomized controlled trial that will recruit individuals who have uncontrolled HTN from 2 EDs in the city of Detroit, with a planned sample size of 396 randomized participants. To be eligible for inclusion, potential participants must be African American, 25 to 70 years old, previously diagnosed with HTN, have a smartphone compatible with MI-BP, and have uncontrolled BP at triage and on repeat measurement at least 1-hour post triage vitals. Once a participant is deemed eligible, all study procedures and subsequent follow-up visits (8 in total) are conducted at the Wayne State University Clinical Research Service Center. We seek to determine the effect of MI-BP on BP for 1 year (using BP control and mean systolic BP as coprimary outcomes and physical activity, sodium intake, and medication adherence as secondary outcomes) compared with usual care controls. RESULTS: Recruitment for this study began in January 2018. The study will continue through 2021. CONCLUSIONS: As the first of its kind conducted in an ED setting, MI-BP was designed to document the efficacy and acceptability of a multicomponent mHealth approach to help African Americans with uncontrolled BP modify their lifestyle to better manage their HTN. We expect to lay the foundation to sustainably reduce HTN-related health disparities through better integration of multiple behavior self-monitoring and improve outcomes for those who traditionally rely on the ED for chronic disease care. TRIAL REGISTRATION: ClinicalTrials.gov NCT02360293; http://clinicaltrials.gov/ct2/show/NCT02360293. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/12601.

MRI and Neuropsychological Correlates in African Americans With Hypertension and Left Ventricular Hypertrophy.

BACKGROUND: African Americans (AAs) are at high risk for hypertension (HTN) and poor blood pressure (BP) control. Persistently elevated BP contributes to cardiovascular morbidity. White matter hyperintensities (WMHs) are a definable magnetic resonance imaging (MRI) marker of cerebrovascular injury linked to impairments in higher level thinking (i.e., executive functions), memory formation, and speed of perceptual-motor processing. METHODS: This subinvestigation evaluated neuropsychological functioning in association with WMH on brain MRIs in 23 otherwise-healthy hypertensive AAs participating in an NIH-funded study of the effects of vitamin D on BP and cardiac remodeling in AA patients 30-74 years of age with HTN and left ventricular hypertrophy. Neuropsychological assessment included psychomotor processing speed [(Symbol Digit Modality Test (SDMT) and Trail Making Test], executive functioning (Controlled Oral Word Association Test and Trail Making Test Part B), memory (Rey Auditory Verbal Learning Test), and fine motor functioning (Finger Tapping). RESULTS: Significant correlations (P < 0.05) were found between volume of periventricular lesions and trails A (r = 0.51) and dominant hand finger tapping speed (r = -0.69) and between subcortical lesion volume and trails A (r = 0.60), both dominant (r = -0.62) and nondominant hand finger tapping speed (r = -0.76) and oral SDMT (r = -0.60); higher lesion volumes correlated to worse neuropsychological performance. CONCLUSIONS: Psychomotor tests including the Trail Making Test and finger tapping speed are sensitive indicators of subclinical deficits in mental processing speed and could serve as early markers of deep subcortical cerebrovascular injury in otherwise-healthy individuals with uncontrolled chronic HTN.

Willingness to pay and willingness to accept in a patient-centered blood pressure control study.

BACKGROUND: Elevated blood pressure is a major risk factor for cardiovascular disease and stroke but patients often discount recommended behavioral changes and prescribed medications. While effective interventions to promote adherence have been developed, cost-effectiveness from the patient's perspective, has not been well studied. The valuation of patient time and out of pocket expenses should be included while performing cost effectiveness evaluation. The Achieve BP study uses the contingent valuation method to assess willingness to accept (WTA) and willingness to pay (WTP) among patients with a history of uncontrolled blood pressure discharged from an urban emergency department and enrolled in a larger randomized controlled trial. METHODS: WTA and WTP were assessed by asking patients a series of questions about time and travel costs and time value related to their study participation. A survey was conducted during the final study visit with patients to investigate the effectiveness of a kiosk-based educational intervention on blood pressure control. All study patients, regardless of study arm, received the same clinical protocol of commonly prescribed antihypertensive medication and met with research clinicians four times as part of the study procedures. RESULTS: Thirty-eight patients were offered the opportunity to participate in the cost-effectiveness study and all completed the survey. Statistical comparisons revealed these 38 patients were similar in representation to the entire RCT study population. All 38 (100.0%) were African-American, with an average age of 49.1 years; 55.3% were male, 21.1% were married, 78.9% had a high school or higher education, and 44.7% were working. 55.9% did not have a primary care provider and 50.0% did not have health insurance. Time price linear regression analysis was performed to estimate predictors of WTA and WTP. CONCLUSIONS: WTP and WTA may generate different results, and the elasticities were proportional to the estimated coefficients, with WTP about twice as responsive as WTA. An additional feature for health services research was successful piloting in a clinical setting of a brief patient-centered cost effectiveness survey. TRIAL REGISTRATION: https://clinicaltrials.gov . Registration Number NCT02069015 . Registered February 19, 2014 (Retrospectively registered).

Text Messaging to Improve Hypertension Medication Adherence in African Americans From Primary Care and Emergency Department Settings: Results From Two Randomized Feasibility Studies.

BACKGROUND: Hypertension (HTN) is an important problem in the United States, with an estimated 78 million Americans aged 20 years and older suffering from this condition. Health disparities related to HTN are common in the United States, with African Americans suffering from greater prevalence of the condition than whites, as well as greater severity, earlier onset, and more complications. Medication adherence is an important component of HTN management, but adherence is often poor, and simply forgetting to take medications is often cited as a reason. Mobile health (mHealth) strategies have the potential to be a low-cost and effective method for improving medication adherence that also has broad reach. OBJECTIVE: Our goal was to determine the feasibility, acceptability, and preliminary clinical effectiveness of BPMED, an intervention designed to improve medication adherence among African Americans with uncontrolled HTN, through fully automated text messaging support. METHODS: We conducted two parallel, unblinded randomized controlled pilot trials with African-American patients who had uncontrolled HTN, recruited from primary care and emergency department (ED) settings. In each trial, participants were randomized to receive either usual care or the BPMED intervention for one month. Data were collected in-person at baseline and one-month follow-up, assessing the effect on medication adherence, systolic and diastolic blood pressure (SBP and DBP), medication adherence self-efficacy, and participant satisfaction. Data for both randomized controlled pilot trials were analyzed separately and combined. RESULTS: A total of 58 primary care and 65 ED participants were recruited with retention rates of 91% (53/58) and 88% (57/65), respectively. BPMED participants consistently showed numerically greater, yet nonsignificant, improvements in measures of medication adherence (mean change 0.9, SD 2.0 vs mean change 0.5, SD 1.5, P=.26), SBP (mean change -12.6, SD 24.0 vs mean change -11.3, SD 25.5 mm Hg, P=.78), and DBP (mean change -4.9, SD 13.1 mm Hg vs mean change -3.3, SD 14.3 mm Hg, P=.54). Control and BPMED participants had slight improvements to medication adherence self-efficacy (mean change 0.8, SD 9.8 vs mean change 0.7, SD 7.0) with no significant differences found between groups (P=.92). On linear regression analysis, baseline SBP was the only predictor of SBP change; participants with higher SBP at enrollment exhibited significantly greater improvements at one-month follow-up (ß=-0.63, P<.001). In total, 94% (51/54) of BPMED participants agreed/strongly agreed that they were satisfied with the program, regardless of pilot setting. CONCLUSIONS: Use of text message reminders to improve medication adherence is a feasible and acceptable approach among African Americans with uncontrolled HTN. Although differences in actual medication adherence and blood pressure between BPMED and usual care controls were not significant, patterns of improvement in the BPMED condition suggest that text message medication reminders may have an effect and fully powered investigations with longer-term follow-up are warranted. TRIAL REGISTRATION: Clinicaltrials.gov NCT01465217; https://clinicaltrials.gov/ct2/show/NCT01465217 (Archived by WebCite at http://www.webcitation.org/6V0tto0lZ).

Patient education and follow-up as an intervention for hypertensive patients discharged from an emergency department: a randomized control trial study protocol.

BACKGROUND: Persistently elevated blood pressure (BP) is a leading risk factor for cardiovascular disease development, making effective hypertension management an issue of considerable public health importance. Hypertension is particularly prominent among African Americans, who have higher disease prevalence and consistently lower BP control than Whites and Hispanics. Emergency departments (ED) have limited resources for chronic disease management, especially for under-served patients dependent upon the ED for primary care, and are not equipped to conduct follow-up. Kiosk-based patient education has been found to be effective in primary care settings, but little research has been done on the effectiveness of interactive patient education modules as ED enhanced discharge for an under-served urban minority population. METHODS/DESIGN: Achieving Blood Pressure Control Through Enhanced Discharge (AchieveBP) is a behavioral RCT patient education intervention for patients with a history of hypertension who have uncontrolled BP at ED discharge. The project will recruit up to 200 eligible participants at the ED, primarily African-American, who will be asked to return to a nearby clinical research center for seven, thirty and ninety day visits, with a 180 day follow-up. Consenting participants will be randomized to either an attention-control or kiosk-based interactive patient education intervention. To control for potential medication effects, all participants will be prescribed similar, evidenced-based anti-hypertensive regimens and have their prescription filled onsite at the ED and during visits to the clinic. The primary target endpoint will be success in achieving BP control assessed at 180 days follow-up post-ED discharge. The secondary aim will be to assess the relationship between patient activation and self-care management. DISCUSSION: The AchieveBP trial will determine whether using interactive patient education delivered through health information technology as ED enhanced discharge with subsequent education sessions at a clinic is an effective strategy for achieving short-term patient management of BP. The project is innovative in that it uses the ED as an initial point of service for kiosk-based health education designed to increase BP self-management. It is anticipated findings from this translational research could also be used as a resource for patient education and follow-up with hypertensive patients in primary care settings. TRIAL REGISTRATION: ClinicalTrials.gov. REGISTRATION NUMBER: NCT02069015. Registered February 19, 2014.