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OpenTrials
Completed

NCT Number: NCT01088854

Acute Effect of Continuous Positive Airway Pressure in Heart Failure

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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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UPECLIN - Botucatu Medical School

Botucatu, São Paulo, 18618-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP

Device

unique session of 30-minute of continuous airway positive pressure

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

UPECLIN HC FM Botucatu Unesp

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 17, 2010
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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