Study Stopped
Difficulty of recruiting patients and cost limitations.
Effects of Continuous Positive Airway Pressure (CPAP) in Heart Remodeling by Magnetic Resonance Imaging (MRI)
OSA-MRI
1 other identifier
interventional
24
1 country
2
Brief Summary
Obstructive sleep apnea (OSA) is independently associated with important heart remodeling that further contributes to overt heart failure. Recent evidences using echocardiogram suggested that continuous positive airway pressure (CPAP) has beneficial effects mainly on left ventricle parameters. However, the evidences regarding the right ventricle are scanty. In addition, no previous studies evaluated morphological and functional characteristics in OSA by magnetic resonance imaging (MRI) as well as the impact of CPAP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2007
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 28, 2008
CompletedFirst Posted
Study publicly available on registry
August 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedNovember 18, 2014
November 1, 2014
3.3 years
July 28, 2008
November 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Right ventricle parameters: size and function.
Baseline and after 3 months.
Secondary Outcomes (1)
Left Ventricle parameters: size and function
Baseline and after 3 months.
Study Arms (2)
1 Control
PLACEBO COMPARATORNo treatment
2 CPAP
EXPERIMENTALContinuous Positive Airway Pressure (CPAP) - REMStar Pro with C-Flex; Respironics, Inc., Murrysville, PA
Interventions
Continuous Positive Airway Pressure (CPAP) during sleep for 3 months.
Eligibility Criteria
You may qualify if:
- Patients free of comorbidities with severe Obstructive Sleep Apnea by polysomnography.
- Healthy volunteers (no obstructive sleep apnea and no comorbidities) matched for age, sex and body mass index.
You may not qualify if:
- Subjects older than 60 years
- Body mass index (BMI) \>40 kg/m2
- Diabetes mellitus
- Hypertension
- Cerebrovascular disease
- Valvular heart disease
- Renal failure
- Current or past smoking history
- Chronic use of any medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Heart Institute (InCor) - University of São Paulo Medical School
São Paulo, São Paulo, 05403-904, Brazil
Heart Institute (InCor)
São Paulo, São Paulo, 05403-904, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luciano F Drager, MD, PhD
Hypertension Unit, Heart Institute (InCor)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Luciano F. Drager
Study Record Dates
First Submitted
July 28, 2008
First Posted
August 4, 2008
Study Start
July 1, 2007
Primary Completion
October 1, 2010
Study Completion
December 1, 2010
Last Updated
November 18, 2014
Record last verified: 2014-11