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The Genetics of Cardiomyopathy and Heart Failure
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by University of California, Irvine.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
University of California, Irvine
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00703443
First received: June 19, 2008
Last updated: February 1, 2010
Last verified: April 2009
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Purpose
The purpose of this study is to determine the genetic basis of cardiomyopathies and heart failure.
| Condition |
|---|
| Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Mitochondrial Cardiomyopathy Noncompaction Cardiomyopathy Restrictive Cardiomyopathy |
| Study Type: | Observational |
| Study Design: | Observational Model: Family-Based Time Perspective: Retrospective |
| Official Title: | The Genetics of Cardiomyopathy and Heart Failure |
Resource links provided by NLM:
Genetics Home Reference related topics:
X-linked dilated cardiomyopathy
familial dilated cardiomyopathy
familial hypertrophic cardiomyopathy
familial restrictive cardiomyopathy
left ventricular noncompaction
Genetic and Rare Diseases Information Center resources:
Dilated Cardiomyopathy
Aortic Valve Stenosis
U.S. FDA Resources
Further study details as provided by University of California, Irvine:
Biospecimen Retention: Samples With DNA
Detailed Description:
Whole blood, Saliva, Buccal cells
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703443
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703443
Locations
| United States, California | |
| University of California, Irvine | |
| Irvine, California, United States, 92697 | |
Sponsors and Collaborators
University of California, Irvine
Investigators
| Principal Investigator: | Michael V Zaragoza, M.D., Ph.D. | University of California, Irvine |
More Information
Publications:
| Responsible Party: | Michael V. Zaragoza, M.D., Ph.D., Assistant Clinical Professor, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00703443 History of Changes |
| Other Study ID Numbers: |
HS# 2007-5577 NIH/NHLBI 5K08HL081222-02 |
| Study First Received: | June 19, 2008 |
| Last Updated: | February 1, 2010 |
Keywords provided by University of California, Irvine:
|
Genetics Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Mitochondrial Cardiomyopathy |
Noncompaction Cardiomyopathy Restrictive Cardiomyopathy Heart Failure |
Additional relevant MeSH terms:
|
Heart Failure Cardiomyopathies Hypertrophy Cardiomyopathy, Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Restrictive Heart Diseases |
Cardiovascular Diseases Pathological Conditions, Anatomical Cardiomegaly Aortic Stenosis, Subvalvular Aortic Valve Stenosis Heart Valve Diseases |
ClinicalTrials.gov processed this record on August 18, 2017