Acute Effect of Continuous Positive Airway Pressure in Heart Failure
This study is enrolling participants by invitation only.
Sponsor:
UPECLIN HC FM Botucatu Unesp
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
| Tracking Information | |||||
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| First Received Date ICMJE | October 16, 2009 | ||||
| Last Updated Date | April 29, 2010 | ||||
| Start Date ICMJE | October 2009 | ||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE |
isovolumetric relaxation time and tissue Doppler-derived mitral annulus diastolic velocities. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01088854 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE |
walk test six minutes [ Time Frame: 30 minutes ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Acute Effect of Continuous Positive Airway Pressure in Heart Failure | ||||
| Official Title ICMJE | Acute Effect of Continuous Positive Airway Pressure on Left Ventricular Diastolic Function and Exercise Tolerance in Compensated Heart Failure | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic |
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| Condition ICMJE | Heart Failure | ||||
| Intervention ICMJE | Device: CPAP
unique session of 30-minute of continuous airway positive pressure |
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| Study Arm (s) | Experimental: positive airway pressure
Intervention: Device: CPAP |
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| Publications * | Bradley TD, Logan AG, Kimoff RJ, Sériès 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 2 | ||||
| Estimated Completion Date | November 2010 | ||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01088854 | ||||
| Other Study ID Numbers ICMJE | upeclin/HC/FMB-Unesp-30 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Beatriz Bojikian Matsubara, Faculdade de Medicina de Botucatu - Unesp | ||||
| Study Sponsor ICMJE | UPECLIN HC FM Botucatu Unesp | ||||
| Collaborators ICMJE | Fundação de Amparo à Pesquisa do Estado de São Paulo | ||||
| Investigators ICMJE |
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| Information Provided By | UPECLIN HC FM Botucatu Unesp | ||||
| Verification Date | April 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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