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

Sponsor:

ClinicalTrials.gov Identifier:

NCT00703443

First Posted: June 23, 2008

Last Update Posted: February 2, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

University of California, Irvine

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

MedlinePlus related topics: Cardiomyopathy Heart Failure

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

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)

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.

Eligibility

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

Zaragoza MV, Arbustini E, Narula J. Noncompaction of the left ventricle: primary cardiomyopathy with an elusive genetic etiology. Curr Opin Pediatr. 2007 Dec;19(6):619-27. Review.


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
First Submitted:	June 19, 2008
First Posted:	June 23, 2008
Last Update Posted:	February 2, 2010
Last Verified:	April 2009

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

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