Acute Effect of Continuous Positive Airway Pressure in Heart Failure

NCT01088854 | Completed Phase 2

• 1 other identifier: upeclin/HC/FMB-Unesp-30
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• walk distance in the walk-test-six-minute (WT6M)

  30 minutes

Study Arms (1)

positive airway pressure

EXPERIMENTAL

Device: CPAP

Interventions

CPAP DEVICE

unique session of 30-minute of continuous airway positive pressure

positive airway pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• functional class II or III (NYHA)heart failure
• agreement to participate in the study
• absence of acute exacerbation of dyspnea
• intact upper airway

You may not qualify if:

• 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

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

UPECLIN - Botucatu Medical School

Botucatu, São Paulo, 18618-000, Brazil

Location

Related Publications (2)

• 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.

  PMID: 16282177 BACKGROUND

• 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.

  PMID: 24838902 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Beatriz B Matsubara, MD

  Full Professor Botucatu Medical School; UNESP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: mester

Study Record Dates

• First Submitted: October 16, 2009
• First Posted: March 17, 2010
• Study Start: October 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 23, 2015

Record last verified: 2010-04

Locations

BR (1)