Acute Effect of Continuous Positive Airway Pressure in Heart Failure

Phase 2

Completed

• Conditions: Heart Failure
• Interventions: Device: CPAP

• Registration Number: NCT01088854
• Lead Sponsor: UPECLIN HC FM Botucatu Unesp

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-16
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-17
• Status Verified: 2010-04
• Primary Completion: 2010-04
• Study Completion: 2010-11
• Last Update Submitted: 2015-06-19
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
positive airway pressure	CPAP	-

Primary Outcome Measures

Name	Time	Method
improvement of isovolumetric relaxation time	30 minutes	Doppler-derived isovolumetric time will be measured before and after intervention (CPAP). A decreasing in isovolumetric time after CPAP will be interpretated as an improvement in myocardial relaxation

Secondary Outcome Measures

Name	Time	Method
walk distance in the walk-test-six-minute (WT6M)	30 minutes	subjects will be tested before and after procedure (CPAP). An increasing distance after procedure will be interpretated as improved tolerance to exercise

Trial Locations

Locations (1)

UPECLIN - Botucatu Medical School; 🇧🇷 Botucatu, Sao Paulo, Brazil