Acute Effect of Continuous Positive Airway Pressure in Heart Failure

UPECLIN HC FM Botucatu Unesp

Status and phase: Completed; Phase 2

Conditions: Heart Failure

Treatments: Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01088854

upeclin/HC/FMB-Unesp-30

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 1 patient group

positive airway pressure

Experimental group

Treatment:

Device: CPAP