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

Fundacio Catalana de Pneumologia130 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

130

Conditions

Hypertension Sleep Apnea

Interventions

cpap treatment during sleepDEVICE

CPAP

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Servei de Pneumologia, Hosital general Universitari Vall d'Hebron

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

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 Outcomes

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

Time frame: 3 months

Data from ClinicalTrials.gov

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