Acute Effect of Continuous Positive Airway Pressure in Heart Failure

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT01088854
First received: October 16, 2009
Last updated: April 29, 2010
Last verified: April 2010
  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

Resource links provided by NLM:


Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088854

Locations
Brazil
UPECLIN - Botucatu Medical School
Botucatu, Sao Paulo, Brazil, 18618-000
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Beatriz B Matsubara, MD Full Professor Botucatu Medical School; UNESP
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 18, 2014