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

Obstructive Sleep Apnea Clinical Trial

— POP-ART  

Official title:

Effect of the Continuous Positive Airway Pressure on Blood Pressure and Arterial Stiffness in Obstructive Sleep Apnea Patients With Resistant Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02385864
• Other study ID #: 2013-A00908-37
• Status: Recruiting
• Phase: N/A
• First received: February 26, 2015
• Last updated: March 4, 2016
• Start date: September 2015
• Est. completion date: February 2017

Study information

• Verified date: March 2016
• Source: University Hospital, Grenoble
• Contact: Gilles Barone-Rochette, MD, PhD
• Phone: (+33) 4 76 76 51 72
• Email: gbarone[@]chu-grenoble.fr
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: February 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Coronary Vasospasm
• Hypertension
• Hypertension, Resistant to Conventional Therapy
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Bordeaux
France	Clinique du Tondu	Bordeaux
France	Clinique des Eaux Claires, Groupe Hospitalier Mutualiste	Grenoble
France	Grenoble University Hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean variation in BP at 6 months, assessed by 24h ambulatory BP monitoring		6 months from baseline assessment	No
Secondary	OSA prevalence in patients with resistant hypertension		6 months	No
Secondary	BP variability assessed by home self BP measurments		6 months	No
Secondary	Arterial stiffness assessed by pulse wave velocity and QKD interval		6 months	No
Secondary	Antihypertensive treatment consumption		6 months	No
Secondary	CPAP treatment observance		6 months	No