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Acute Effect of Continuous Positive Airway Pressure in Heart Failure

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ClinicalTrials.gov Identifier: NCT01088854
Recruitment Status : Completed
First Posted : March 17, 2010
Last Update Posted : June 23, 2015
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Marjory Bussoni, 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.


Condition or disease Intervention/treatment Phase
Heart Failure Device: CPAP Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Acute Effect of Continuous Positive Airway Pressure on Left Ventricular Diastolic Function and Exercise Tolerance in Compensated Heart Failure
Study Start Date : October 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: positive airway pressure Device: CPAP
unique session of 30-minute of continuous airway positive pressure



Primary Outcome Measures :
  1. improvement of isovolumetric relaxation time [ Time Frame: 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 :
  1. walk distance in the walk-test-six-minute (WT6M) [ Time Frame: 30 minutes ]
    subjects will be tested before and after procedure (CPAP). An increasing distance after procedure will be interpretated as improved tolerance to exercise



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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