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NCT00459914 Clinical Trial

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

Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00459914
Other study ID # FUCAP2004
Secondary ID
Status Completed
Phase Phase 2
First received April 11, 2007
Last updated January 27, 2009
Start date January 2005
Est. completion date December 2008

Study information
Verified date January 2009
Source Fundacio Catalana de Pneumologia
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of Health and Consumption
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date December 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Device:
• cpap treatment during sleep
CPAP

Locations
Country Name City State
Spain Servei de Pneumologia, Hosital general Universitari Vall d'Hebron Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Fundacio Catalana de Pneumologia

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of 3 months of CPAP versus conventional pharmacological treatment on the mean 24 h systolic and diastolic blood pressure . 3 months No
Secondary Effect of CPAP versus conventional pharmacological treatment on inflammatory, endothelial function and angiogenesis serum biomarkers 3 months No
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