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1.
Vaccine ; 42(3): 496-504, 2024 Jan 25.
Article in English | MEDLINE | ID: mdl-38154990

ABSTRACT

BACKGROUND: Influenza vaccination prevents major cardiovascular events in individuals presenting a recent acute coronary syndrome (ACS), however the early effect of an in-hospital double-dose vaccination strategy remains uncertain. METHODS: The VIP-ACS was a randomized, pragmatic, multicenter, open-label trial with a blinded-adjudication endpoint. Patients with ACS ≤ 7 days of hospitalization were randomized to an in-hospital double-dose quadrivalent inactivated influenza vaccine (double-dose) or a standard-dose influenza vaccine at 30 days post-randomization. The primary endpoint was a hierarchical composite of death, myocardial infarction, stroke, hospitalization for unstable angina, hospitalization for heart failure, urgent coronary revascularization, and hospitalization for respiratory infections, analyzed with the win ratio (WR) method in short-term follow-up (45-days after randomization). RESULTS: The trial enrolled 1,801 patients (≥18 years old). Median participant age was 57 years, 70 % were male. There were no significant differences between groups on the primary hierarchical endpoint: there were 5.7 % wins in the double-dose in-hospital group and 5.5 % wins in the standard-dose delayed vaccination group (WR: 1.03; 95 % CI: 0.70---1.53; P = 0.85). In a sensitivity analysis including COVID-19 infection in the hospitalizations for respiratory infections endpoint, overall results were maintained (WR: 1.03; 95 % CI 0.71---1.51; P = 0.87). Results were consistent for major cardiovascular events only (WR: 0.82; 95 % CI: 0.48---1.39; P = 0.46). No serious adverse events were observed. CONCLUSION: In patients with recent ACS, in-hospital double-dose influenza vaccination did not significantly reduce cardiorespiratory events at 45 days compared with standard-dose vaccination at 30 days post-randomization.


Subject(s)
Acute Coronary Syndrome , Influenza Vaccines , Influenza, Human , Adolescent , Female , Humans , Male , Middle Aged , Acute Coronary Syndrome/therapy , Hospitals , Influenza Vaccines/therapeutic use , Influenza, Human/prevention & control , Risk Factors , Treatment Outcome , Vaccination , Adult , Randomized Controlled Trials as Topic , Pragmatic Clinical Trials as Topic , Multicenter Studies as Topic
2.
Sleep Med ; 112: 316-321, 2023 12.
Article in English | MEDLINE | ID: mdl-37952480

ABSTRACT

Vigorous physical activity has been associated with a reduced risk of developing obstructive sleep apnea (OSA). However, whether high-intensity interval training (HIIT) reduces OSA severity remains unclear. Thus, this study aimed to investigate the impact of 12 weeks of HIIT on the apnea-hypopnea index (AHI) and sleep parameters in participants with moderate-severe OSA. In this randomized controlled trial, 36 adults (19 males; 52.2 ± 9.8 years; body mass index = 34.2 ± 5.8) with moderate to severe OSA (AHI = 42.0 ± 22.9 e/h) were randomly assigned to HIIT [5 periods of 4 min of walking or running on a treadmill at 90-95 % of maximum heart rate (HRmax) interspersed with 3 min of walking at 50-55 % of HRmax performed three times per week for 12 weeks] or a control group (CG; stretching exercises performed two times per week for 12 weeks). Sleep parameters were assessed at baseline and after 12 weeks through overnight polysomnography. Generalized estimated equations assessed differences between groups over time. There was not group × time interaction for body mass index between groups (p = 0.074). However, significant group × time interactions were observed for AHI (CG change = 8.2 ± 3.7, HIIT change = -8.6 ± 4.8; p = 0.005), SaO2 minimum (CG change = -1.6 ± 1.6 %, HIIT change = 0.4 ± 2.3 %; p = 0.030), total sleep time (CG change = -31.5 ± 19.5 min, HIIT change = 33.7 ± 19.3 min; p = 0.049), and sleep efficiency (CG change = -3.2 ± 4.4 %, HIIT change = 9.9 ± 3.5 %; p = 0.026). Moreover, there was a significant time × group interaction for maximum oxygen consumption (VO2max; CG change = -1.1 ± 1.0 mL/kg/min, HIIT change = 4.8 ± 0.9 mL/kg/min; p < 0.001)]. However, In patients with OSA, 12 weeks of HIIT decreases sleep apnea severity, improves sleep quality, and cardiorespiratory fitness. CLINICAL TRIAL REGISTRATION: (Registro Brasileiro de Ensaios Clínicos [ReBec]): # RBR-98jdt3.


Subject(s)
High-Intensity Interval Training , Sleep Apnea Syndromes , Sleep Apnea, Obstructive , Adult , Male , Humans , Sleep Apnea Syndromes/complications , Sleep , Exercise Therapy
3.
Sleep Breath ; 27(2): 765-770, 2023 05.
Article in English | MEDLINE | ID: mdl-35538181

ABSTRACT

PURPOSE: To evaluate arterial stiffness, a predictor of vascular damage was assessed by means of pulse wave velocity (PWV) in patients with chronic obstructive pulmonary disease (COPD) and comorbid obstructive sleep apnea (OSA), namely overlap syndrome (OS). METHODS: Consecutive stable patients with COPD were evaluated for OSA by means of overnight polysomnography in the laboratory. A clinical assessment was performed according to a strict protocol, including two COPD questionnaires: the COPD assessment test and the modified Medical Research Council scale. COPD severity was graded according to the guidelines of the Global Initiative for Chronic Obstructive Lung Disease. Arterial stiffness was assessed by means of PWV, using a standard technique. RESULTS: Of 102 patients with COPD, 51 had associated OSA. The OS group had more men than the COPD group (73% vs. 47%, respectively; p < 0.01). Both groups had similar ages (66.2 ± 9.2 years vs. 69.6 ± 10.7, p = 0.09) and airflow limitation (p = 0.37). Hypertension was found in 22% of COPD patients, as opposed to 17% patients in the OS group (p = 0.29). High PWV values were present in 42% of the patients. Patients with COPD and OS had the same PWV values (9.8 vs. 10.5 m/s, p = 0.34). There were no differences in central blood pressure, peripheral blood pressure, and augmentation index between the two groups (p > 0.05). CONCLUSION: High PWV values were frequently observed in patients with COPD. However, there was no difference in PWV between patients with OS and those with COPD alone.


Subject(s)
Hypertension , Pulmonary Disease, Chronic Obstructive , Sleep Apnea, Obstructive , Vascular Stiffness , Male , Humans , Vascular Stiffness/physiology , Pulse Wave Analysis , Pulmonary Disease, Chronic Obstructive/diagnosis , Pulmonary Disease, Chronic Obstructive/epidemiology , Pulmonary Disease, Chronic Obstructive/complications , Sleep Apnea, Obstructive/complications , Sleep Apnea, Obstructive/diagnosis , Sleep Apnea, Obstructive/epidemiology , Syndrome
4.
Eur Heart J ; 43(41): 4378-4388, 2022 11 01.
Article in English | MEDLINE | ID: mdl-36030400

ABSTRACT

AIMS: To evaluate whether a strategy of double-dose influenza vaccination during hospitalization for an acute coronary syndrome (ACS) compared with standard-dose outpatient vaccination (as recommended by current guidelines) would further reduce the risk of major cardiopulmonary events. METHODS AND RESULTS: Vaccination against Influenza to Prevent cardiovascular events after Acute Coronary Syndromes (VIP-ACS) was a pragmatic, randomized, multicentre, active-comparator, open-label trial with blinded outcome adjudication comparing two strategies of influenza vaccination following an ACS: double-dose quadrivalent inactivated vaccine before hospital discharge vs. standard-dose quadrivalent inactivated vaccine administered in the outpatient setting 30 days after randomization. The primary outcome was a hierarchical composite of all-cause death, myocardial infarction, stroke, unstable angina, hospitalization for heart failure, urgent coronary revascularization, and hospitalization for respiratory causes, analysed by the win ratio method. Patients were followed for 12 months. During two influenza seasons, 1801 participants were included at 25 centres in Brazil. The primary outcome was not different between groups, with 12.7% wins in-hospital double-dose vaccine group and 12.3% wins in the standard-dose vaccine group {win ratio: 1.02 [95% confidence interval (CI): 0.79-1.32], P = 0.84}. Results were consistent for the key secondary outcome, a hierarchical composite of cardiovascular death, myocardial infarction and stroke [win ratio: 0.94 (95% CI: 0.66-1.33), P = 0.72]. Time-to-first event analysis for the primary outcome showed results similar to those of the main analysis [hazard ratio 0.97 (95% CI: 0.75-1.24), P = 0.79]. Adverse events were infrequent and did not differ between groups. CONCLUSION: Among patients hospitalized with an ACS, double-dose influenza vaccination before discharge did not reduce cardiopulmonary outcomes compared with standard-dose vaccination in the outpatient setting. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number: NCT04001504.


Subject(s)
Acute Coronary Syndrome , Influenza, Human , Myocardial Infarction , Stroke , Humans , Acute Coronary Syndrome/therapy , Influenza, Human/prevention & control , Myocardial Infarction/prevention & control , Vaccination , Stroke/prevention & control , Vaccines, Inactivated , Treatment Outcome
5.
J Bras Pneumol ; 48(3): e20220191, 2022 07 08.
Article in English, Portuguese | MEDLINE | ID: mdl-35830058
6.
J Bras Pneumol ; 48(3): e20210340, 2022.
Article in English, Portuguese | MEDLINE | ID: mdl-35508063

ABSTRACT

OBJECTIVE: To evaluate clinical predictors of poor sleep quality in COPD patients with and without obstructive sleep apnea (OSA). METHODS: Consecutive stable patients with COPD were evaluated for OSA by means of overnight polysomnography; for sleep quality by means of the Pittsburgh Sleep Quality Index (PSQI); and for disease impact by means of the COPD Assessment Test. COPD severity was graded in accordance with the 2020 GOLD guidelines. Predictors of poor sleep quality were evaluated by multivariate logistic regression analysis. RESULTS: We studied 51 patients with COPD alone and 51 patients with COPD and OSA. Both groups had similar age (66.2 ± 9.2 years vs. 69.6 ± 10.7, p = 0.09) and airflow limitation (p = 0.37). Poor sleep quality was present in 74.8% of the study participants, with no significant difference between COPD patients with and without OSA regarding PSQI scores (p = 0.73). Polysomnography showed increased stage 1 non-rapid eye movement sleep and arousal index, as well as reduced sleep efficiency and stage 3 non-rapid eye movement sleep, in the group of patients with COPD and OSA (p < 0.05). Independent predictors of poor sleep quality were GOLD grade C/D COPD (OR = 6.4; 95% CI, 1.79-23.3; p < 0.01), a COPD Assessment Test score ≥ 10 (OR = 12.3; 95% CI, 4.1-36.5; p < 0.01), and lowest SaO2 < 80% (p < 0.0001). CONCLUSIONS: Poor sleep quality is quite common in patients with COPD and is associated with severe COPD and poor health status, having a negative impact on overall quality of life. Despite changes in polysomnography, OSA appears to have no impact on subjective sleep quality in COPD patients.


Subject(s)
Pulmonary Disease, Chronic Obstructive , Sleep Apnea, Obstructive , Aged , Humans , Middle Aged , Pulmonary Disease, Chronic Obstructive/complications , Quality of Life , Severity of Illness Index , Sleep Apnea, Obstructive/complications , Sleep Quality
7.
J Strength Cond Res ; 36(5): 1222-1227, 2022 May 01.
Article in English | MEDLINE | ID: mdl-32379244

ABSTRACT

ABSTRACT: Santiago, LCS, Lyra, MJ, Germano-Soares, AH, Lins-Filho, OL, Queiroz, DR, Prazeres, TMP, Mello, MT, Pedrosa, RP, Falcão, APST, and Santos, MAM. Effects of strength training on sleep parameters of adolescents: a randomized controlled trial. J Strength Cond Res 36(5): 1222-1227, 2022-This study aimed to examine the effects of 12 weeks of strength training (ST) on sleep quality and daytime sleepiness in adolescents with sleep complaints. Thirty adolescents were randomly assigned to 2 groups: ST group (ST, n = 18) and control group (CG, n = 12). Anthropometric, body composition, one-repetition maximum test, and sleep parameters (Pittsburgh Sleep Quality Index [PSQI] and Epworth Sleepiness Scale [ESS]) were evaluated. Training consisted of 55 min·d-1 (3 times a week, for 12 weeks), 3 sets of 10-12 repetitions with a 1-minute rest interval between sets and exercises. Baseline and postintervention differences were analyzed using Generalized Estimating Equations and the effect size (ES) with Cohen's d coefficient. Significance was set at (p < 0.05). After 12 weeks of ST, a significant decrease in the PSQI score (7.3 ± 0.7 vs. 5.1 ± 0.6; ES = 4.10) was observed in the ST group, but not in the CG (6.3 ± 0.8 vs. 7.4 ± 0.7; ES = 1.53). A significant decrease in ESS score was found in the ST group (10.1 ± 0.7 vs. 8.2 ± 0.7; ES = 3.08), without differences in the CG (10.7 ± 0.8 vs. 11.0 ± 0.7; ES = 0.56). The ST group presented increased total sleep duration (h·min-1) (6.2 ± 0.2 vs. 6.9 ± 0.2; ES = 3.60), but not the CG (7.0 ± 0.2 vs. 6.8 ± 0.1; ES = 1.32). Individual analyses showed ≈67% of adolescents experienced a reduction in PSQI (8.3; confidence interval [CI] 95% 6.8-10.1) and ESS (8.3; CI 95% 6.7-9.9) scores after ST, whereas only ≈17% of control subjects presented reduced scores (PSQI [11.1; CI 95% 9.5-12.9] and ESS [11.0; CI 95% 9.4-12.6]). Strength training improved sleep quality and increased total sleep duration.


Subject(s)
Resistance Training , Sleep Wake Disorders , Adolescent , Body Composition , Exercise , Humans , Sleep
8.
J. bras. pneumol ; 48(3): e20210340, 2022. tab, graf
Article in English | LILACS, BIGG - GRADE guidelines | ID: biblio-1375742

ABSTRACT

To evaluate clinical predictors of poor sleep quality in COPD patients with and without obstructive sleep apnea (OSA). Methods: Consecutive stable patients with COPD were evaluated for OSA by means of overnight polysomnography; for sleep quality by means of the Pittsburgh Sleep Quality Index (PSQI); and for disease impact by means of the COPD Assessment Test. COPD severity was graded in accordance with the 2020 GOLD guidelines. Predictors of poor sleep quality were evaluated by multivariate logistic regression analysis. Results: We studied 51 patients with COPD alone and 51 patients with COPD and OSA. Both groups had similar age (66.2 ± 9.2 years vs. 69.6 ± 10.7, p = 0.09) and airflow limitation (p = 0.37). Poor sleep quality was present in 74.8% of the study participants, with no significant difference between COPD patients with and without OSA regarding PSQI scores (p = 0.73). Polysomnography showed increased stage 1 non-rapid eye movement sleep and arousal index, as well as reduced sleep efficiency and stage 3 non-rapid eye movement sleep, in the group of patients with COPD and OSA (p < 0.05). Independent predictors of poor sleep quality were GOLD grade C/D COPD (OR = 6.4; 95% CI, 1.79-23.3; p < 0.01), a COPD Assessment Test score ≥ 10 (OR = 12.3; 95% CI, 4.1-36.5; p < 0.01), and lowest SaO2 < 80% (p < 0.0001). Conclusions: Poor sleep quality is quite common in patients with COPD and is associated with severe COPD and poor health status, having a negative impact on overall quality of life. Despite changes in polysomnography, OSA appears to have no impact on subjective sleep quality in COPD patients.


Avaliar os preditores clínicos de má qualidade do sono em pacientes com DPOC, com e sem apneia obstrutiva do sono (AOS). Métodos: Pacientes estáveis consecutivos com DPOC foram avaliados quanto à AOS por meio de polissonografia noturna; quanto à qualidade do sono por meio do Índice de Qualidade do Sono de Pittsburgh (IQSP) e quanto ao impacto da doença por meio do Teste de Avaliação da DPOC. A gravidade da DPOC foi classificada conforme as diretrizes de 2020 da GOLD. Os preditores de má qualidade do sono foram avaliados por meio de análise de regressão logística multivariada. Resultados: Foram estudados 51 pacientes com DPOC apenas e 51 pacientes com DPOC e AOS. Ambos os grupos eram semelhantes quanto à idade (66,2 ± 9,2 anos vs. 69,6 ± 10,7, p = 0,09) e limitação do fluxo aéreo (p = 0,37). Sono de má qualidade esteve presente em 74,8% dos participantes, sem diferença significativa entre os pacientes com DPOC, com e sem AOS, quanto à pontuação no IQSP (p = 0,73). A polissonografia mostrou aumento do estágio 1 do sono non-rapid eye movement e do índice de despertares, bem como redução da eficiência do sono e do estágio 3 do sono non-rapid eye movement nos pacientes com DPOC e AOS (p < 0,05). Os preditores independentes de má qualidade do sono foram DPOC grau C/D da GOLD (OR = 6,4; IC95%: 1,79-23,3; p < 0,01), pontuação ≥ 10 no Teste de Avaliação da DPOC (OR = 12,3; IC95%: 4,1-36,5; p < 0,01) e menor SaO2 < 80% (p < 0,0001). Conclusões: O sono de má qualidade é bastante comum em pacientes com DPOC e apresenta relação com DPOC grave e estado de saúde ruim, além de ter impacto negativo na qualidade de vida global. Não obstante as alterações na polissonografia, a AOS aparentemente não tem impacto na qualidade do sono referida por pacientes com DPOC.


Subject(s)
Humans , Aged , Sleep Apnea, Obstructive/complications , Pulmonary Disease, Chronic Obstructive/complications , Sleep Quality , Polysomnography
10.
Clinics (Sao Paulo) ; 76: e2926, 2021.
Article in English | MEDLINE | ID: mdl-34495079

ABSTRACT

OBJECTIVES: To describe the MORPHEOS (Morbidity in patients with uncontrolled HTN and OSA) trial, and describe the challenges imposed by the COVID-19 pandemic. METHODS: MORPHEOS is a multicenter (n=6) randomized controlled trial designed to evaluate the blood pressure (BP) lowering effects of treatment with continuous positive airway pressure (CPAP) or placebo (nasal strips) for 6 months in adult patients with uncontrolled hypertension (HTN) and moderate-to-severe obstructive sleep apnea (OSA). Patients using at least one antihypertensive medication were included. Uncontrolled HTN was confirmed by at least one abnormal parameter in the 24-hour ABPM and ≥80% medication adherence evaluated by pill counting after the run-in period. OSA was defined by an apnea-hypopnea index ≥15 events/hours. The co-primary endpoints are brachial BP (office and ambulatory BP monitoring, ABPM) and central BP. Secondary outcomes include hypertension-mediated organ damage (HMOD) to heart, aorta, eye, and kidney. We pre-specified several sub-studies from this investigation. Visits occur once a week in the first month and once a month thereafter. The programmed sample size was 176 patients but the pandemic prevented this final target. A post-hoc power analysis will be calculated from the final sample. ClinicalTrials.gov: NCT02270658. RESULTS: The first 100 patients are predominantly males (n=69), age: 52±10 years, body mass index: 32.7±3.9 kg/m2 with frequent co-morbidities. CONCLUSIONS: The MORPHEOS trial has a unique study design including a run-in period; pill counting, and detailed analysis of hypertension-mediated organ damage in patients with uncontrolled HTN that will allow clarification of the impact of OSA treatment with CPAP.


Subject(s)
COVID-19 , Hypertension , Sleep Apnea, Obstructive , Adult , Blood Pressure , Continuous Positive Airway Pressure , Humans , Hypertension/epidemiology , Hypertension/therapy , Male , Middle Aged , Pandemics , SARS-CoV-2 , Sleep Apnea, Obstructive/therapy
11.
Blood Press Monit ; 26(3): 224-229, 2021 Jun 01.
Article in English | MEDLINE | ID: mdl-33577184

ABSTRACT

AIM: Patients with masked hypertension have a higher incidence of target organ damage, including increased left ventricular mass and carotid atherosclerosis and cardiovascular events when compared with normotensive patients. The adverse cardiovascular risks are even greater in patients already taking antihypertensive medication. OBJECTIVE: To identify the prevalence and clinical characteristics of masked hypertension in a large multicenter Brazilian sample that underwent office and home blood pressure monitoring. METHODS: This was an observational cross-sectional analytical study based on secondary data from the teleMRPA online platform, which included 32 cities from 15 states in the five regions of Brazil. The database included 3704 outpatient participants with office blood pressure <140/90 mmHg who performed home blood pressure monitoring for diagnostic investigation (diagnosis group; n = 1819) or treatment (treatment group; n = 1885) of hypertension in 2018. RESULTS: The prevalence of masked hypertension was 18.0% in the whole studied population and 15.4% and 20.4% in the diagnostic and treatment group, respectively. Masked hypertension was more frequently detected in patients with office blood pressure classified as high normal [systolic blood pressure (SBP) = 130-139 mmHg or diastolic blood pressure (DBP) = 85-89 mmHg], followed by those classified as normal (SBP = 120-129 mmHg or DBP = 80-84 mmHg) and optimal (SBP < 120 mmHg and DBP < 80 mmHg), with respective prevalence of 28.3, 13.4 and 4.4% in the diagnostic group and 30.8, 18.8 and 7.1% in the treatment group. CONCLUSION: Masked hypertension has a significant prevalence among individuals with office blood pressure <140/90 mmHg, which is greater with patients with high normal office blood pressure and even higher in patients already using antihypertensive medication.


Subject(s)
Hypertension , Masked Hypertension , Blood Pressure , Blood Pressure Monitoring, Ambulatory , Brazil/epidemiology , Cross-Sectional Studies , Humans , Hypertension/drug therapy , Hypertension/epidemiology , Masked Hypertension/diagnosis , Masked Hypertension/drug therapy , Masked Hypertension/epidemiology , Prevalence
12.
Sleep Breath ; 25(3): 1195-1202, 2021 Sep.
Article in English | MEDLINE | ID: mdl-33094411

ABSTRACT

PURPOSE: This study aimed to perform a systematic review and meta-analysis of randomized trials investigating the effect of continuous positive airway pressure (CPAP) on non-invasive markers of arterial stiffness in patients with OSA. METHODS: The purpose of the study was to evaluate the effect of CPAP on markers of arterial stiffness (pulse wave velocity (PWV) and augmentation index (Aix)) in patients with OSA. The study adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We systematically reviewed MEDLINE, EMBASE, CENTRAL/CCTR, SciELO, and LILACS databases for randomized trials (RT) evaluating the changes in markers of arterial stiffness (pulse wave velocity (PWV) and augmentation index (Aix) comparing CPAP vs. controls in patients with OSA. Reviewer Manager version 5.3 (R Foundation for Statistical Computing, Vienna, Austria) was used to perform meta-analysis. Risk of bias analysis was performed using the Cochrane tool. RESULTS: Of the 464 studies initially retrieved, 9 relevant studies with 685 participants were included in the analysis. The studies presented moderate risk of bias. CPAP did not significantly reduce Aix (mean difference, - 1.96 (95% confidence interval (CI) - 5.25 to 1.33), p = 0.24), whereas it significantly changed PWV (mean difference, - 0.44 (95% confidence interval (CI) - 0.76 to - 0.12), p = 0.00). CONCLUSION: CPAP treatment was effective in improving arterial stiffness by reducing PWV in patients with OSA. Additional randomized trials, however, should be performed to confirm these findings.


Subject(s)
Continuous Positive Airway Pressure , Sleep Apnea, Obstructive/therapy , Vascular Stiffness/physiology , Humans , Randomized Controlled Trials as Topic , Sleep Apnea, Obstructive/physiopathology , Treatment Outcome
13.
Clinics ; 76: e2926, 2021. tab, graf
Article in English | LILACS | ID: biblio-1339699

ABSTRACT

OBJECTIVES: To describe the MORPHEOS (Morbidity in patients with uncontrolled HTN and OSA) trial, and describe the challenges imposed by the COVID-19 pandemic. METHODS: MORPHEOS is a multicenter (n=6) randomized controlled trial designed to evaluate the blood pressure (BP) lowering effects of treatment with continuous positive airway pressure (CPAP) or placebo (nasal strips) for 6 months in adult patients with uncontrolled hypertension (HTN) and moderate-to-severe obstructive sleep apnea (OSA). Patients using at least one antihypertensive medication were included. Uncontrolled HTN was confirmed by at least one abnormal parameter in the 24-hour ABPM and ≥80% medication adherence evaluated by pill counting after the run-in period. OSA was defined by an apnea-hypopnea index ≥15 events/hours. The co-primary endpoints are brachial BP (office and ambulatory BP monitoring, ABPM) and central BP. Secondary outcomes include hypertension-mediated organ damage (HMOD) to heart, aorta, eye, and kidney. We pre-specified several sub-studies from this investigation. Visits occur once a week in the first month and once a month thereafter. The programmed sample size was 176 patients but the pandemic prevented this final target. A post-hoc power analysis will be calculated from the final sample. ClinicalTrials.gov: NCT02270658. RESULTS: The first 100 patients are predominantly males (n=69), age: 52±10 years, body mass index: 32.7±3.9 kg/m2 with frequent co-morbidities. CONCLUSIONS: The MORPHEOS trial has a unique study design including a run-in period; pill counting, and detailed analysis of hypertension-mediated organ damage in patients with uncontrolled HTN that will allow clarification of the impact of OSA treatment with CPAP.


Subject(s)
Humans , Male , Adult , Middle Aged , Sleep Apnea, Obstructive/therapy , COVID-19 , Hypertension/therapy , Hypertension/epidemiology , Blood Pressure , Continuous Positive Airway Pressure , Pandemics , SARS-CoV-2
16.
J Sleep Res ; 29(2): e12954, 2020 04.
Article in English | MEDLINE | ID: mdl-31868987

ABSTRACT

Obstructive sleep apnea (OSA) is a common condition among patients with hypertension and treatment with continuous positive airway pressure (CPAP) can decrease blood pressure (BP). However, CPAP is not well tolerated by a significant proportion of patients. The authors investigated the effects of acupuncture on OSA severity and BP control in patients with hypertension. Hypertensive patients with mild to moderate OSA (apnea-hypopnea index, 5-30 events/hr) were randomly assigned to receive acupuncture or sham-acupuncture treatment. Patients were assessed at baseline and after 10 acupuncture sessions using polysomnography, 24-hr ambulatory BP monitoring and a quality of life questionnaire. Forty-four patients (34% men; mean age, 57.0 ± 5.4 years; body mass index, 29.6 ± 3.2 kg/m2 ; apnea-hypopnea index, 16.3 ± 6.7 events/hr) completed the study. There were no differences in pre-post-intervention apnea-hypopnea index, daytime or nocturnal BP, or quality of life between the acupuncture and sham-acupuncture groups (p > .05). Acupuncture therapy in hypertensive patients with OSA did not reduce OSA severity, daytime or nocturnal BP, or quality of life.


Subject(s)
Acupuncture Therapy/methods , Blood Pressure/physiology , Hypertension/therapy , Quality of Life/psychology , Sleep Apnea, Obstructive/therapy , Female , Humans , Male , Middle Aged
17.
J Hypertens ; 38(4): 663-670, 2020 04.
Article in English | MEDLINE | ID: mdl-31790056

ABSTRACT

OBJECTIVE: The current study investigated the prevalence of white-coat hypertension (WCH) and white-coat uncontrolled hypertension (WUCH) throughout the age spectrum among individuals with office isolated systolic hypertension (ISH), isolated diastolic hypertension (IDH) and systolic-diastolic hypertension (SDH) who were untreated or treated with antihypertensive medications, respectively. METHODS: We cross-sectionally evaluated 8809 untreated (42% males, 52.1 ±â€Š16.2 years) and 9136 treated (39% males, 59.7 ±â€Š14.5 years) individuals from two independent Brazilian populations who underwent home blood pressure monitoring. Participants were also categorized as younger (<40 years), intermediate (≥40 and <60 years) and older (≥60 years) age. RESULTS: Unadjusted and adjusted analyses showed that the frequency of WCH and WUCH was significantly greater (P < 0.05) in ISH and IDH than SDH at all age groups. Logistic regression analysis adjusted for sex, BMI and studied population showed that, compared with SDH, ISH had in average 4.1, 3.1 and 1.6-fold greater risk of WCH and 3.3, 3.6 and 2.0-fold greater risk of WUCH at younger, intermediate and older ages, whereas IDH had in average 2.3, 2.6 and 2.0-fold greater risk of WCH and 3.8, 3.2 and 3.8-fold greater risk of WUCH at younger, intermediate and older ages, respectively. CONCLUSION: ISH and IDH were associated with higher prevalence of WCH and WUCH than SDH across all age spectrum. In addition, treated and untreated ISH individuals with age less than 60 years and treated IDH individuals of all ages had the highest risk of having WCH phenotypes.


Subject(s)
Blood Pressure Monitoring, Ambulatory , Hypertension/epidemiology , White Coat Hypertension/epidemiology , Adult , Aged , Antihypertensive Agents/therapeutic use , Blood Pressure , Brazil/epidemiology , Female , Humans , Hypertension/drug therapy , Hypertension/physiopathology , Male , Middle Aged , Prevalence , White Coat Hypertension/drug therapy , White Coat Hypertension/physiopathology
18.
Hypertens Res ; 42(11): 1816-1823, 2019 11.
Article in English | MEDLINE | ID: mdl-31263210

ABSTRACT

The values used to define the presence of white-coat or masked blood pressure (BP) effects are arbitrary. The aim of this study was to investigate the accuracy of several cutoff points based on the difference between office and home BP (ΔBP) values to detect white-coat uncontrolled (WUCH) and masked uncontrolled (MUCH) hypertension, which are phenotypes with adverse prognoses, in a large cohort of treated hypertensive patients. This multicenter cross-sectional study included 6,049 treated hypertensive patients (40% males, mean age 59.1 ± 14.4 years) who underwent office and home BP monitoring. We compared the sensitivity, specificity, area under curve (AUC), and positive (PPV) and negative (NPV) predictive values of several ΔBP cutoffs to detect WUCH and MUCH. The 15/9 mmHg cutoff, which reflects a 1.0 standard deviation of the ΔBP, showed the best AUC (0.783, 95% CI = 0.772-0.794) for the detection of WUCH, particularly in individuals with office grade 1 hypertension (AUC = 0.811, 95% CI = 0.793-0.829). The -1/-1 mmHg cutoff, which considers all individuals who had lower systolic or diastolic BP levels in the office than at home, had the highest AUC (0.822, 95% CI = 0.808-0.836) for the detection of MUCH. Both cutoff values also had the best performances for identifying all patients with higher and lower office-than-home BP grades. In conclusion, the 15/9 and -1/-1 mmHg cutoffs showed the best performance for the detection of treated hypertensive patients with WUCH and MUCH, respectively, and therefore might be markers of significant white-coat and masked effects and could be useful for identifying preferential targets for more routine home BP measures.


Subject(s)
Blood Pressure Monitoring, Ambulatory/standards , Masked Hypertension/diagnosis , White Coat Hypertension/diagnosis , Aged , Cross-Sectional Studies , Female , Humans , Male , Middle Aged
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