Acute Effect of Continuous Positive Airway Pressure in Heart Failure

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

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-11-30

Brief Summary

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Acute effects of CPAP on diastolic function in patients with compensated heart failure (CHF) are unknown. The investigators hypothesized that acutely CPAP improves diastolic function, which is associated with increases exercise tolerance.

Objective: To evaluate the acute effects of CPAP on functional capacity and diastolic indices of patients with CHF. This is a randomized trial including 44 patients with compensated heart failure (functional classes II or III, NYHA). Patients will be allocated in CPAP(CPAP with 10cmH2O) or simulated CPAP (null pressure) after computed randomization, in a 1:1 ratio. All subjects shall complete a 6-minute walk test (6MWT) before and after CPAP (30 minutes; 10 cm H2O pressure). Doppler-echocardiogram will be performed before and at the end of CPAP. Wilcoxon or paired t tests were used to compare results, with significance level at p \< 0.05.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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positive airway pressure

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

unique session of 30-minute of continuous airway positive pressure

Interventions

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CPAP

unique session of 30-minute of continuous airway positive pressure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* functional class II or III (NYHA)heart failure
* agreement to participate in the study
* absence of acute exacerbation of dyspnea
* intact upper airway

Exclusion Criteria

* valvular heart disease
* chest pain or unstable angina
* acute myocardial infarction in the prior month
* uncontrolled hypertension
* atrial fibrillation or other arrhythmias
* acute infection
* orthopedic limitations
* intolerance to CPAP mask

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No