Effects of Continuous Positive Airway Pressure (CPAP) in Heart Remodeling by Magnetic Resonance Imaging (MRI) (OSA-MRI)
Primary Purpose
Obstructive Sleep Apnea
Status
Terminated
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
CPAP
No treatment
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, CPAP, Heart remodeling, Cardiovascular disease, MRI
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Heart Institute (InCor)
- Heart Institute (InCor) - University of São Paulo Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1 Control
2 CPAP
Arm Description
No treatment
Continuous Positive Airway Pressure (CPAP) - REMStar Pro with C-Flex; Respironics, Inc., Murrysville, PA
Outcomes
Primary Outcome Measures
Right ventricle parameters: size and function.
Secondary Outcome Measures
Left Ventricle parameters: size and function
Full Information
NCT ID
NCT00727454
First Posted
July 28, 2008
Last Updated
November 14, 2014
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT00727454
Brief Title
Effects of Continuous Positive Airway Pressure (CPAP) in Heart Remodeling by Magnetic Resonance Imaging (MRI)
Acronym
OSA-MRI
Official Title
Effects of Continuous Positive Airway Pressure on Heart Remodeling in Patients With Obstructive Sleep Apnea: A Randomized Study With Cardiovascular Magnetic Resonance Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Difficulty of recruiting patients and cost limitations.
Study Start Date
July 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The patients will be recruited from the Sleep Laboratory, Heart Institute (InCor), University of São Paulo Medical School. Male adults with a sleep study within 1 month showing severe OSA (>30 events of apnea and hypopnea per hour of sleep) and naive to treatment will be considered for the study. Age and body mass index matched controls will be recruited from the hospital staff and their relatives. All volunteers will be previously screening for the risk of OSA with Berlin Questionnaire. To minimize confounding risk factors, we will exclude subjects older than 60 years and those with a body mass index (BMI) >40 kg/m2, diabetes mellitus, hypertension, cerebrovascular disease, valvular heart disease, renal failure, current or past smoking history, and chronic use of any medication. Hypertension will be excluded after 3 or more normal blood pressure values (<140/90mm Hg) obtained on separate occasions with a conventional mercury sphygmomanometer.
Sleep Study. All participants will perform a standard overnight polysomnography. Apnea will be defined as complete cessation of airflow for at least 10 seconds, associated with oxygen desaturation of 3%. Hypopnea will be defined as a significant reduction (>50%) in respiratory signals for at least 10 seconds associated with oxygen desaturation of 3%. The apnea-hypopnea index will be calculated as the total number of respiratory events (apneas plus hypopneas) per hour of sleep. Normal values will be considered when the apnea-hypopnea index will be <5events/hour.
The participants will be randomly assigned to no treatment (control) or treatment with CPAP for 3 months, according to a computer-generated list of random numbers. At baseline and after 3 months, the participants will be submitted to cardiac MRI.
Magnetic resonance imaging methods. Participants will perform MRI examination on 1.5 - T GE CV/i system. Short and long-axis of the heart will be obtained during breath-hold and triggered on electrocardiogram pulse sequences. The first sequence will be a gradient-echo (steady-sate free procession) to assess left ventricular (LV) and right ventricular (RV) morphology and function. The second sequence will be an inversion-recovery prepared gradient-echo to obtain MDE (10 to 20 minutes after intravenous bolus of 0.2 mmol/Kg of gadolinium-based contrast). We will use the following parameters: repetition time 3.9/7.1ms, echo time 1.7/3.1 ms, flip angle 45º/20º, cardiac phases 20/1, views per segment 8/16 to 32, matrix 256 x 128/256 x 192, slice thickness 8/8mm, gap between slices 2/2mm and field of view 32 to 38/32 to 38 cm, inversion time none/150 to 250 ms, receiver bandwidth 125/31,25 kHz, number of excitations 1/2.
Blood Samples. Venous blood will be collected from all participants between 8 and 10 AM for the measurement of glucose, total cholesterol, low-density lipoprotein, high-density lipoprotein, and red blood cell count.
24-hour blood pressure monitoring. All participants will be submitted to a 24-hour blood pressure monitoring with a SpaceLabs device (model 90207).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, CPAP, Heart remodeling, Cardiovascular disease, MRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Control
Arm Type
Placebo Comparator
Arm Description
No treatment
Arm Title
2 CPAP
Arm Type
Experimental
Arm Description
Continuous Positive Airway Pressure (CPAP) - REMStar Pro with C-Flex; Respironics, Inc., Murrysville, PA
Intervention Type
Device
Intervention Name(s)
CPAP
Other Intervention Name(s)
CPAP REMStar Pro with C-Flex; Respironics, Inc.
Intervention Description
Continuous Positive Airway Pressure (CPAP) during sleep for 3 months.
Intervention Type
Device
Intervention Name(s)
No treatment
Intervention Description
No treatment
Primary Outcome Measure Information:
Title
Right ventricle parameters: size and function.
Time Frame
Baseline and after 3 months.
Secondary Outcome Measure Information:
Title
Left Ventricle parameters: size and function
Time Frame
Baseline and after 3 months.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciano F Drager, MD, PhD
Organizational Affiliation
Hypertension Unit, Heart Institute (InCor)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute (InCor)
City
Sao Paulo
ZIP/Postal Code
05403-904
Country
Brazil
Facility Name
Heart Institute (InCor) - University of São Paulo Medical School
City
São Paulo
ZIP/Postal Code
05403-904
Country
Brazil
12. IPD Sharing Statement
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Effects of Continuous Positive Airway Pressure (CPAP) in Heart Remodeling by Magnetic Resonance Imaging (MRI)
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