- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00703443
The Genetics of Cardiomyopathy and Heart Failure
January 22, 2021 updated by: University of California, Irvine
The purpose of this study is to determine the genetic basis of cardiomyopathies and heart failure.
Study Overview
Status
Withdrawn
Detailed Description
The purpose of this research study is to explore the causes and inheritances of cardiomyopathies.
Cardiomyopathies are serious medical conditions that result in a wide range of cardiac problems, from no symptoms at all to heart failure.
The underlying genetics of cardiomyopathies are poorly understood.
This study will collect personal, family, and medical history information to create a database of participants with cardiomyopathies.
This information will be used to identify inheritance patterns within families with cardiomyopathies.
In addition, samples from participants will be studied in the lab to see if any changes in their genetic information can be identified that would cause a cardiomyopathy.
Overall, the research study is aimed at determining the cause of these cardiac conditions so that tests and treatments might be developed in the future.
Study Type
Observational
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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California
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Irvine, California, United States, 92697
- University of California, Irvine
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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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
We are recruiting both local participants (who have been evaluated at UCI) and remote participants (who have been referred from outside UCI) with familial and simplex cases of hypertrophic, dilated, noncompaction, restrictive, and mitochondrial cardiomyopathies.
As a control group, we are also recruiting patients with nuclear mutations known to increase the risk of cardiomyopathy, but who have not themselves developed cardiomyopathy.
Description
Inclusion Criteria:
- Individuals with a diagnosis of cardiomyopathy
- Family members of individuals with a diagnosis of cardiomyopathy
- Individuals with a nuclear mutation shown to confer risk of cardiomyopathy but who do not themselves have cardiomyopathy
Exclusion Criteria:
- Individuals who do not have cardiomyopathy, a relative with cardiomyopathy, or a nuclear mutation predisposing to cardiomyopathy
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael V Zaragoza, M.D., Ph.D., University of California, Irvine
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
April 1, 2007
Primary Completion (ACTUAL)
April 1, 2007
Study Completion (ACTUAL)
April 1, 2007
Study Registration Dates
First Submitted
June 19, 2008
First Submitted That Met QC Criteria
June 19, 2008
First Posted (ESTIMATE)
June 23, 2008
Study Record Updates
Last Update Posted (ACTUAL)
January 25, 2021
Last Update Submitted That Met QC Criteria
January 22, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Genetic Diseases, Inborn
- Pathological Conditions, Anatomical
- Aortic Valve Disease
- Heart Valve Diseases
- Cardiomegaly
- Laminopathies
- Aortic Stenosis, Subvalvular
- Aortic Valve Stenosis
- Heart Failure
- Hypertrophy
- Cardiomyopathies
- Cardiomyopathy, Dilated
- Cardiomyopathy, Hypertrophic
- Cardiomyopathy, Restrictive
Other Study ID Numbers
- HS# 2007-5577
- NIH/NHLBI 5K08HL081222-02
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.
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