Clinical trial NCT02385864: CPAP Effect on Blood Pressure and Arterial Stiffness in Obstructive Sleep Apnea Patients With Resistant Hypertension
Official title: Effect of the Continuous Positive Airway Pressure on Blood Pressure and Arterial Stiffness in Obstructive Sleep Apnea Patients With Resistant Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension, Resistant to Conventional Therapy
Obstructive Sleep Apnea
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with resistant hypertension

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean variation in BP at 6 months, assessed by 24h ambulatory BP monitoring
timeFrame: 6 months from baseline assessment
Secondary outcomes:
measure: OSA prevalence in patients with resistant hypertension
timeFrame: 6 months
measure: BP variability assessed by home self BP measurments
timeFrame: 6 months
measure: Arterial stiffness assessed by pulse wave velocity and QKD interval
timeFrame: 6 months
measure: Antihypertensive treatment consumption
timeFrame: 6 months
measure: CPAP treatment observance
timeFrame: 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique du Tondu
city: Bordeaux
country: France
facility: Bordeaux University Hospital
city: Grenoble
country: France
facility: Clinique des Eaux Claires, Groupe Hospitalier Mutualiste
city: Grenoble
country: France
facility: Grenoble University Hospital
Study officials:
affiliation: Groupe Hospitalier Mutualiste, Grenoble
name: Jean-Philippe Baguet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: