CPAP Effect on Blood Pressure and Arterial Stiffness in Obstructive Sleep Apnea Patients With Resistant Hypertension (POP-ART)

March 4, 2016 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

166

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Recruiting
        • Clinique du Tondu
        • Contact:
      • Bordeaux, France, 33075
      • Grenoble, France, 38700
        • Recruiting
        • Grenoble University Hospital
        • Contact:
        • Contact:
      • Grenoble, France, 38000
        • Recruiting
        • Clinique des Eaux Claires, Groupe Hospitalier Mutualiste
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with resistant hypertension

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean variation in BP at 6 months, assessed by 24h ambulatory BP monitoring
Time Frame: 6 months from baseline assessment
6 months from baseline assessment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Jean-Philippe Baguet, MD, PhD, Groupe Hospitalier Mutualiste, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

March 7, 2016

Last Update Submitted That Met QC Criteria

March 4, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-A00908-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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