Sleep Apnea and Refractory Hypertension: Prevalence and Effect of CPAP Treatment

Phase 2

Completed

• Conditions: Hypertension; Sleep Apnea
• Interventions: Device: cpap treatment during sleep

• Registration Number: NCT00459914
• Lead Sponsor: Fundacio Catalana de Pneumologia

Brief Summary

A small number of uncontrolled studies have shown a high prevalence of sleep apnea in patients with refractory hypertension and that CPAP treatment achieves a significant reduction of blood pressure in the short term.

The purpose of this study is to assess the prevalence of sleep apnea in patients with refractory hypertension, and the effects of continuous positive pressure treatment on systemic blood pressure and on serum markers of endothelial dysfunction and angiogenesis.

Detailed Description

We assess the prevalence of an apnea hypopnea index (AHI) \> 5 in patients with refractory hypertension referred from a hypertension clinic. Patients with an AHI \>15 are randomized to either continuing their usual pharmacological treatment alone or adding CPAP to their usual treatment, during a 3 month period.

The main endpoint is the comparison of the mean 24h systolic and diastolic blood pressure, as assessed by ambulatory blood pressure monitoring, between both treatment arms. The secondary endpoint is to assess changes in serum markers of endothelial dysfunction and angiogenesis

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2007-04-11
• Study First Submitted QC: 2007-04-11
• Study First Posted: 2007-04-13
• Primary Completion: 2008-05
• Study Completion: 2008-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-27
• Last Update Posted: 2009-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Patients referred from a tertiary hospital hypertension clinic with a diagnosis of refractory hypertension on the basis of office blood pressure higher then 160/90 mmHg despite the recommended doses of at least 3 drugs, including a diuretic.

Exclusion Criteria

• Causes of secondary hypertension, history of alcohol abuse , renal insufficiency, severe chronically illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 CPAP	cpap treatment during sleep	Nasal continuous positive airway pressure

Primary Outcome Measures

Name	Time	Method
Effect of 3 months of CPAP versus conventional pharmacological treatment on the mean 24 h systolic and diastolic blood pressure .	3 months

Secondary Outcome Measures

Name	Time	Method
Effect of CPAP versus conventional pharmacological treatment on inflammatory, endothelial function and angiogenesis serum biomarkers	3 months

Trial Locations

Locations (1)

Servei de Pneumologia, Hosital general Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain