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

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Hypertension Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1 CPAP

Nasal continuous positive airway pressure

Group Type ACTIVE_COMPARATOR

cpap treatment during sleep

Intervention Type DEVICE

CPAP

2

Pharmacological treatment alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cpap treatment during sleep

CPAP

Intervention Type DEVICE

Eligibility Criteria

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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.