Acute Effect of Continuous Positive Airway Pressure in Heart Failure
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Device: CPAP |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic |
| Official Title: | Acute Effect of Continuous Positive Airway Pressure on Left Ventricular Diastolic Function and Exercise Tolerance in Compensated Heart Failure |
- improvement of isovolumetric relaxation time [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]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
- walk distance in the walk-test-six-minute (WT6M) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]subjects will be tested before and after procedure (CPAP). An increasing distance after procedure will be interpretated as improved tolerance to exercise
| Estimated Enrollment: | 2 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: positive airway pressure |
Device: CPAP
unique session of 30-minute of continuous airway positive pressure
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Brazil | |
| UPECLIN - Botucatu Medical School | |
| Botucatu, Sao Paulo, Brazil, 18618-000 | |
| Principal Investigator: | Beatriz B Matsubara, MD | Full Professor Botucatu Medical School; UNESP |
More Information
Publications:
| Responsible Party: | Beatriz Bojikian Matsubara, Faculdade de Medicina de Botucatu - Unesp |
| ClinicalTrials.gov Identifier: | NCT01088854 History of Changes |
| Other Study ID Numbers: | upeclin/HC/FMB-Unesp-30 |
| Study First Received: | October 16, 2009 |
| Last Updated: | April 29, 2010 |
| Health Authority: | Brazil: Ethics Committee |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013