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Acute Effect of Continuous Positive Airway Pressure in Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01088854
First Posted: March 17, 2010
Last Update Posted: June 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Marjory Bussoni, UPECLIN HC FM Botucatu Unesp
  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
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 2
Study Start Date: October 2009
Study Completion Date: November 2010
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

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marjory Bussoni, mester, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT01088854     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-30
First Submitted: October 16, 2009
First Posted: March 17, 2010
Last Update Posted: June 23, 2015
Last Verified: April 2010

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases