- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01631006
Effects of Continous Positive Airway Pressure (CPAP) in Hypertrophic Cardiomyopathy (CPAPandHCM)
December 18, 2014 updated by: Geraldo Lorenzi-Filho, University of Sao Paulo
Acute Hemodynamic Effects of Continous Positive Airway Pressure (CPAP) in Patients With Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiac disease, is a cause of disability including heart failure, atrial fibrillation, and sudden death, with an annual mortality varying from 1% to 6%.
Obstructive sleep apnea (OSA) is extremely common among patients with established cardiovascular disease, including hypertension and atrial fibrillation and when present may contribute to worse cardiovascular outcome.
Although patients with HCM do not necessarily have typical characteristics of patients with OSA, such as obesity and increasing age, there is recent evidence that OSA is extremely common among patients with HCM, with a prevalence ranging from 32% to 71%.
The presence of OSA among patients with HCM is independently associated with worse structural and functional impairment of the heart, including atrial and aorta enlargement, worse New York Heart Association functional class, and worse quality of life.
Therefore, the recognition and treatment of OSA is a new area of research that may impact in the management of patients with HCM.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sao Paulo, Brazil, 05403000
- Heart Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- both genders
- over 18 years-old
- hemodynamically stable
- with no other cardiac disease
- consent form signed
Exclusion Criteria:
- presence of pacemaker
- spontaneous withdrawal
- previous cardiorespiratory arrest
- atrial fibrilation during echocardiography
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Low CPAP pressure
Patients are submmited to a CPAP with low pressure for 20 minutes
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A low or high CPAP pressure is delivered for 20 minutes
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Active Comparator: High CPAP pressure
Patients are submmited to a high pressure of CPAP for 20 minutes
|
A low or high CPAP pressure is delivered for 20 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cadiac performance by echocardiography
Time Frame: acutely
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acutely
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
June 26, 2012
First Submitted That Met QC Criteria
June 27, 2012
First Posted (Estimate)
June 28, 2012
Study Record Updates
Last Update Posted (Estimate)
December 19, 2014
Last Update Submitted That Met QC Criteria
December 18, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDC 325209/003
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 Non-obstructive Hypertrophic Cardiomyopathy
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French Cardiology SocietyCompleted1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy | 2- Obstructive Hypertrophic Cardiomyopathy | 3- Non Obstructive Hypertrophic CardiomyopathyFrance
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Bristol-Myers SquibbActive, not recruitingHypertrophic Cardiomyopathy | Non-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyDenmark, United States, Belgium, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom
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MyoKardia, Inc.CompletedNon-obstructive Hypertrophic CardiomyopathyUnited States
-
Imbria Pharmaceuticals, Inc.CompletedNon-obstructive Hypertrophic CardiomyopathyUnited States, United Kingdom
-
Morten Steen Kvistholm JensenOdense University Hospital; Zealand University Hospital; Rigshospitalet, Denmark and other collaboratorsRecruitingNon-obstructive Hypertrophic CardiomyopathyDenmark
-
IRCCS San RaffaeleMenarini International Operations Luxembourg SACompletedHCM - Hypertrophic Non-Obstructive CardiomyopathyItaly
-
CytokineticsRecruitingSymptomatic Non-Obstructive Hypertrophic CardiomyopathyUnited States
-
SuZhou Sinus Medical Technologies Co.,LtdNot yet recruiting
-
Bristol-Myers SquibbActive, not recruitingHOCM, Hypertrophic Obstructive CardiomyopathyUnited States
-
Shaare Zedek Medical CenterMedtronicUnknownHOCM, Hypertrophic Obstructive Cardiomyopathy
Clinical Trials on CPAP
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State Key Laboratory of Respiratory DiseaseCompletedSleep Apnea, Obstructive | Continuous Positive Airway Pressure | PolysomnographyChina
-
University of ZurichSwiss National Science FoundationCompleted
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Chinese University of Hong KongCompleted
-
Ulysses Magalang MDTerminatedObstructive Sleep ApneaUnited States
-
Krishna M. SundarCompleted
-
University Hospital, GrenobleCompleted
-
The Hospital for Sick ChildrenCompletedObesity | Cardiovascular Disease | Obstructive Sleep Apnea | Sleep DisordersCanada
-
Fisher and Paykel HealthcareSuburban Lung AssociatesCompletedSleep Apnea, ObstructiveUnited States
-
University Hospital, LilleCompletedSleep Apnea Syndromes | Epilepsies, PartialFrance
-
Ohio State UniversityCompletedHeart Failure | Obstructive Sleep Apnea | Heart Failure, CongestiveUnited States