- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00727454
Effects of Continuous Positive Airway Pressure (CPAP) in Heart Remodeling by Magnetic Resonance Imaging (MRI) (OSA-MRI)
Effects of Continuous Positive Airway Pressure on Heart Remodeling in Patients With Obstructive Sleep Apnea: A Randomized Study With Cardiovascular Magnetic Resonance Imaging
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Sao Paulo, Brazil, 05403-904
- Heart Institute (InCor)
-
São Paulo, Brazil, 05403-904
- Heart Institute (InCor) - University of São Paulo Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1 Control
No treatment
|
No treatment
|
Experimental: 2 CPAP
Continuous Positive Airway Pressure (CPAP) - REMStar Pro with C-Flex; Respironics, Inc., Murrysville, PA
|
Continuous Positive Airway Pressure (CPAP) during sleep for 3 months.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Right ventricle parameters: size and function.
Time Frame: Baseline and after 3 months.
|
Baseline and after 3 months.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Left Ventricle parameters: size and function
Time Frame: Baseline and after 3 months.
|
Baseline and after 3 months.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Luciano F Drager, MD, PhD, Hypertension Unit, Heart Institute (InCor)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3163/08/79
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea
-
LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
-
Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
-
University of California, Los AngelesRecruiting
-
Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
-
State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
-
The Hospital for Sick ChildrenCompleted
-
Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
-
State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
-
Somnics, Inc.UnknownObstructive Sleep Apnea of AdultTaiwan
-
ApnimedCompletedOSA - Obstructive Sleep ApneaUnited States
Clinical Trials on No treatment
-
HealthpointCompletedVenous Leg Ulcer (VLU)Germany, Poland, Belgium, Hungary, Czechia
-
HealthpointCompleted
-
University Hospital, GrenobleUnknownObstructive Sleep Apnea Syndrome | HypertensionFrance
-
Anna Alessandri BonettiCompletedPain | Sleep Apnea Syndromes | Sleep Apnea, Obstructive | Sleep Apnea | Temporomandibular Disorder | Pain, FaceItaly
-
Guangzhou Medical UniversityThe Children's Hospital of Zhejiang University School of Medicine; Gansu Provincial... and other collaboratorsRecruiting
-
National Cancer Institute (NCI)Active, not recruitingBrain Cancer | Brain Tumor | Neoplasm | Spine Cancer | Spine TumorUnited States
-
Rigshospitalet, DenmarkNovo Nordisk A/SCompletedDepression | Brain Diseases | Quality of Life | Physical ImpairmentDenmark
-
University College, LondonWellcome Trust; National Institute for Health Research, United KingdomUnknownMyocardial Infarction | Heart Failure | Stroke | Ischemic Stroke | Peripheral Arterial Disease | Transient Ischemic Attack | Stable Angina Pectoris | Unstable Angina | Abdominal Aortic Aneurysm | Intracerebral Haemorrhage | Subarachnoid Haemorrhage | Coronary Heart Disease NOS | Unheralded Corronary Death | Cardiac...United Kingdom
-
AllerganCompleted