Acute Effect of Continuous Positive Airway Pressure in Heart Failure

Acute Effect of Continuous Positive Airway Pressure on Left Ventricular Diastolic Function and Exercise Tolerance in Compensated Heart Failure

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01088854

Enrollment

Registered

2010-03-17

Start date

2009-10-31

Completion date

2010-11-30

Last updated

2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

DEVICECPAP

unique session of 30-minute of continuous airway positive pressure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026