Exercise Tolerance in Patients With Decompensated Heart Failure

Heart Failure Clinical Trial

Official title:

Effects of Bilevel Positive Airway Pressure on Exercise Tolerance in Patients With Decompensated Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122848
• Other study ID #: hsl 2013-48
• Status: Completed
• Phase: N/A
• First received: April 20, 2014
• Last updated: April 20, 2015
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Hospital Sirio-Libanes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of airway bilevel positive pressure on the improvement of exercise tolerance in patients with decompensated heart failure.

Description:

Heart failure causes limitation of functional capacity and worsening of exercise tolerance. The airway pressure as adjuvant of cardiac rehabilitation has demonstrated improvement of functional capacity, decrease of respiratory work, increase of oxygenation and pulmonary compliance. Objective: to evaluate the effectiveness of the bilevel positive airway pressure (BILEVEL) in the increase of exercise tolerance in patients with decompensated heart failure. Method: this is a cross-over randomized clinical trial, with individuals who will undergo a submaximal progressive exercise test of the lower limbs with a cycle-ergometer using continuous positive airway pressure (CPAP) and BILEVEL in a random order. Patients will also be evaluated using a health related quality of life questionnaire, pulmonary function test, inspiratory muscle and peripheral muscle strength tests. Hypothesis: The increase in exercise tolerance might be greater during the use of BILEVEL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• subjects who has heart failure functional class II or III of New York heart association

• over 18 years

• non-smokers

• without cognitive or motor deficit

• without vasoactive drugs or low doses

• without recent acute myocardial myocardium (<1 year)

• without recent cardiac surgery (<1 year)

• without pulmonary disease

• without bronchodilators

Exclusion Criteria:

• unstable angina

• atrial fibrillation and atrioventricular block third degree

• frequent vomiting

• respiratory instability while collecting data

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• BiLevel
The intervention will be performed using BiLevel ventilation mode with EPAP=10 cmH2O and a IPAP which manages 6-8ml/kg tidal volume.

Locations

Country	Name	City	State
Brazil	Hospitalsiriolibanes	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endurance time of exercise in cycle ergometer.		4 days	Yes
Secondary	Dyspnea	Dyspnea will be evaluated by means of the modified Borg scale before and after exercise.	4 days	Yes