Acute Effect of Continuous Positive Airway Pressure in Heart Failure

Heart Failure Clinical Trial

Official title:

Acute Effect of Continuous Positive Airway Pressure on Left Ventricular Diastolic Function and Exercise Tolerance in Compensated Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088854
• Other study ID #: upeclin/HC/FMB-Unesp-30
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2009
• Last updated: June 19, 2015
• Start date: October 2009
• Est. completion date: November 2010

Study information

• Verified date: April 2010
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: November 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• CPAP
unique session of 30-minute of continuous airway positive pressure

Locations

Country	Name	City	State
Brazil	UPECLIN - Botucatu Medical School	Botucatu	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 minutes	No
Secondary	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	30 minutes	No