CPAP Effect on Blood Pressure and Arterial Stiffness in Obstructive Sleep Apnea Patients With Resistant Hypertension

• Conditions: Obstructive Sleep Apnea; Hypertension, Resistant to Conventional Therapy

• Registration Number: NCT02385864
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

Resistant hypertension is defined as uncontrolled blood pressure (BP ≥ 140/90mmHg) despite the current use of three or more antihypertensive drugs at full doses, including a diuretic. Obstructive Sleep Apnea (OSA) is at high risk for cardiovascular morbidity and is highly prevalent in patients with resistant hypertension.

The prospective observational POP-ART study will assess the efficacy of continuous positive airway pressure (CPAP) treatment on BP in patients with resistant hypertension and collect data from usual care.

Detailed Description

Obstructive Sleep Apnea is highly prevalent in patients with resistant hypertension and several studies have assessed the effect of CPAP treatment on BP.

But only few studies have raised data about the effect of CPAP treatment on BP in patients with resistant hypertension.

Hypertension is moreover associated with increased arterial stiffness, but no data are available in patients with resistant hypertension.

The purpose of this study is to demonstrate that OSA has a major impact in resistant hypertension, whose effects on BP and arterial stiffness can partially be reversible with CPAP treatment.

Study Timeline

• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-11
• Study Start: 2015-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-04
• Last Update Posted: 2016-03-07
• Primary Completion: 2016-08
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

• Patient with resistant hypertension uncontrolled by 3 or more antihypertensive agents
• Patient with severe OSA (apnea-hypopnea index > 30 or > or equal to 15 with excessive daytime sleepiness), or with mild to moderate OSA without excessive daytime sleepiness, or without OSA.
• Ambulatory patient

Exclusion Criteria

• Body mass index ≥40 kg/m2
• Other identifiable causes of hypertension
• Contraindication to CPAP treatment or patient already treated with CPAP

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean variation in BP at 6 months, assessed by 24h ambulatory BP monitoring	6 months from baseline assessment

Secondary Outcome Measures

Name	Time	Method
OSA prevalence in patients with resistant hypertension	6 months
BP variability assessed by home self BP measurments	6 months
Arterial stiffness assessed by pulse wave velocity and QKD interval	6 months
Antihypertensive treatment consumption	6 months
CPAP treatment observance	6 months

Trial Locations

Locations (4)

Bordeaux University Hospital; 🇫🇷 Bordeaux, France

Clinique du Tondu; 🇫🇷 Bordeaux, France

Clinique des Eaux Claires, Groupe Hospitalier Mutualiste; 🇫🇷 Grenoble, France

Grenoble University Hospital; 🇫🇷 Grenoble, France