Exercise Tolerance in Patients With Decompensated Heart Failure
Effects of Bilevel Positive Airway Pressure on Exercise Tolerance in Patients With Decompensated Heart Failure
1 other identifier
interventional
16
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Apr 2014
Shorter than P25 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 20, 2014
CompletedFirst Posted
Study publicly available on registry
April 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedApril 22, 2015
April 1, 2015
1 year
April 20, 2014
April 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endurance time of exercise in cycle ergometer.
4 days
Secondary Outcomes (1)
Dyspnea
4 days
Study Arms (1)
Bilevel
EXPERIMENTALThe intervention will be performed using BiLevel ventilation mode with EPAP=10 cmH2O and a IPAP which manages 6-8ml/kg tidal volume.
Interventions
The intervention will be performed using BiLevel ventilation mode with EPAP=10 cmH2O and a IPAP which manages 6-8ml/kg tidal volume.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- unstable angina
- atrial fibrillation and atrioventricular block third degree
- frequent vomiting
- respiratory instability while collecting data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospitalsiriolibanes
São Paulo, São Paulo, 01308-050, Brazil
Related Publications (1)
Moraes IG, Kimoto KM, Fernandes MB, Grams ST, Yamaguti WP. Adjunctive Use of Noninvasive Ventilation During Exercise in Patients With Decompensated Heart Failure. Am J Cardiol. 2017 Feb 1;119(3):423-427. doi: 10.1016/j.amjcard.2016.10.025. Epub 2016 Nov 1.
PMID: 27939229DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wellington Yamaguti
Hospital Sirio-Libanes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Wellington Pereira dos Santos Yamaguti
Study Record Dates
First Submitted
April 20, 2014
First Posted
April 25, 2014
Study Start
April 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
April 22, 2015
Record last verified: 2015-04