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

Primary Purpose

Hypertension, Sleep Apnea

Status

Completed

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

cpap treatment during sleep

About this trial

This is an interventional supportive care trial for Hypertension focused on measuring sleep apnea, refractory hypertension, continuous positive airway pressure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Servei de Pneumologia, Hosital general Universitari Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1 CPAP

Arm Description

Nasal continuous positive airway pressure

Pharmacological treatment alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effect of CPAP versus conventional pharmacological treatment on inflammatory, endothelial function and angiogenesis serum biomarkers

Full Information

NCT ID

NCT00459914

First Posted

April 11, 2007

Last Updated

January 27, 2009

Sponsor

Fundacio Catalana de Pneumologia

1. Study Identification

Unique Protocol Identification Number

NCT00459914

Brief Title

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

Official Title

Sleep Apnea in Patients With Refractory Hypertension: Study of the Prevalence and the Effect of CPAP Treatment on Blood Pressure Control, Endothelial Dysfunction and Angiogenesis.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Fundacio Catalana de Pneumologia

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Sleep Apnea

Keywords

sleep apnea, refractory hypertension, continuous positive airway pressure

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 CPAP

Arm Type

Active Comparator

Arm Description

Nasal continuous positive airway pressure

Arm Title

Arm Type

No Intervention

Arm Description

Pharmacological treatment alone

Intervention Type

Device

Intervention Name(s)

cpap treatment during sleep

Intervention Description

CPAP

Primary Outcome Measure Information:

Title

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Effect of CPAP versus conventional pharmacological treatment on inflammatory, endothelial function and angiogenesis serum biomarkers

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: