The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic.
Clinics (Sao Paulo)
; 76: e2926, 2021.
Article
in English
| MEDLINE | ID: covidwho-1399567
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.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Sleep Apnea, Obstructive
/
COVID-19
/
Hypertension
Type of study:
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Limits:
Adult
/
Humans
/
Male
/
Middle aged
Language:
English
Journal:
Clinics (Sao Paulo)
Journal subject:
Medicine
Year:
2021
Document Type:
Article
Affiliation country:
Clinics
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