Acute Effect of Continuous Positive Airway Pressure in Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
CPAP
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure
Eligibility 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
Sites / Locations
- UPECLIN - Botucatu Medical School
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
positive airway pressure
Arm Description
Outcomes
Primary Outcome Measures
improvement of isovolumetric relaxation time
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)
subjects will be tested before and after procedure (CPAP). An increasing distance after procedure will be interpretated as improved tolerance to exercise
Full Information
NCT ID
NCT01088854
First Posted
October 16, 2009
Last Updated
June 19, 2015
Sponsor
UPECLIN HC FM Botucatu Unesp
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01088854
Brief Title
Acute Effect of Continuous Positive Airway Pressure in Heart Failure
Official Title
Acute Effect of Continuous Positive Airway Pressure on Left Ventricular Diastolic Function and Exercise Tolerance in Compensated Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UPECLIN HC FM Botucatu Unesp
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
positive airway pressure
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
unique session of 30-minute of continuous airway positive pressure
Primary Outcome Measure Information:
Title
improvement of isovolumetric relaxation time
Description
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
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
walk distance in the walk-test-six-minute (WT6M)
Description
subjects will be tested before and after procedure (CPAP). An increasing distance after procedure will be interpretated as improved tolerance to exercise
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz B Matsubara, MD
Organizational Affiliation
Full Professor Botucatu Medical School; UNESP
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPECLIN - Botucatu Medical School
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18618-000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
16282177
Citation
Bradley TD, Logan AG, Kimoff RJ, Series F, Morrison D, Ferguson K, Belenkie I, Pfeifer M, Fleetham J, Hanly P, Smilovitch M, Tomlinson G, Floras JS; CANPAP Investigators. Continuous positive airway pressure for central sleep apnea and heart failure. N Engl J Med. 2005 Nov 10;353(19):2025-33. doi: 10.1056/NEJMoa051001.
Results Reference
background
PubMed Identifier
24838902
Citation
Bussoni MF, Guirado GN, Matsubara LS, Roscani MG, Polegato BF, Minamoto ST, Bazan SG, Matsubara BB. Diastolic function and functional capacity after a single session of continuous positive airway pressure in patients with compensated heart failure. Clinics (Sao Paulo). 2014;69(5):354-9. doi: 10.6061/clinics/2014(05)010.
Results Reference
derived
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Acute Effect of Continuous Positive Airway Pressure in Heart Failure
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