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

NCT ID: NCT02385864

Last Updated: 2016-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-02-28

Brief Summary

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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

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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.

Conditions

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Hypertension, Resistant to Conventional Therapy Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Philippe Baguet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier Mutualiste, Grenoble

Locations

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Clinique du Tondu

Bordeaux, , France

Site Status RECRUITING

Bordeaux University Hospital

Bordeaux, , France

Site Status RECRUITING

Clinique des Eaux Claires, Groupe Hospitalier Mutualiste

Grenoble, , France

Site Status RECRUITING

Grenoble University Hospital

Grenoble, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gilles Barone-Rochette, MD, PhD

Role: CONTACT

(+33) 4 76 76 51 72

Jean-Louis Pepin, MD, PhD

Role: CONTACT

(+33) 4 76 76 92 65

Facility Contacts

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Olivier Coste, MD

Role: primary

(+33) 5 56 99 62 67

Philippe Gosse, Md, PhD

Role: primary

(+33)5 56 79 58 89

Jean-Philippe Baguet, MD, PhD

Role: primary

(+33)4 76 70 70 54

Christophe Dessus

Role: backup

(+33) 4 76 70 76 98

Gilles Barone-Rochette, MD, PhD

Role: primary

(+33) 4 76 76 51 72

Jean-Louis Pepin, MD, PhD

Role: backup

(+33)4 76 76 92 65

Other Identifiers

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2013-A00908-37

Identifier Type: -

Identifier Source: org_study_id

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