Completed

Family Studies of Hypertrophic Cardiomyopathy

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What is being collected

Data Collection

Who is being recruted

Aortic Valve Disease+5

+ Aortic Stenosis, Subvalvular

+ Aortic Valve Stenosis

See all eligibility criteria
How is the trial designed

Observational
Study Start: April 1987
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1987

Actual date on which the first participant was enrolled.

Hypertrophic cardiomyopathy (HCM) is the most important cause of sudden death in apparently healthy young individuals but its clinical manifestations are highly variable. Linkage analysis is used to localize a gene causing an inherited autosomal dominant disease, such as HCM. Linkage analysis requires that large families be evaluated clinically to determine the members with and without the disease. For this study, DNA needs to be extracted from blood samples of family members. The presence of the disease is determined by history and physical exam, 12 lead ECG and 2-D echocardiogram. The likelihood of localizing the gene increases with the size of the family and the number of members evaluated. The beta myosin heavy chain (beta-MHC) gene has been shown to be responsible for HCM in 10%-30% of affected kindreds. Other linage studies have shown that there are at least 3 other genes which cause HCM in other kindreds, but these genes are presently unknown. We have identified 13 unique mutations in the beta-MHC gene which cause the disease in 17 kindreds. This has allowed us to demonstrate skeletal muscle involvement, study the abnormal physiology which is a consequence of the mutations, make pre-symptomatic diagnosis, and redefine the natural history of the disease. In order to continue our clinical and laboratory studies of this disease over the next 3 years, it is our intention to identify 50 additional HCM kindreds, with approximately 50 members each, that have beta-MHC gene mutations. During this time, in order to map other HCM genes, we will also evaluate at least 6 families, of approximately 300 members each, in which the disease is not linked to the beta-MHC gene.

NCT00001225
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

5880 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Aortic Valve DiseaseAortic Stenosis, SubvalvularAortic Valve StenosisCardiovascular DiseasesHeart DiseasesHeart Valve DiseasesCardiomyopathiesCardiomyopathy, Hypertrophic

Criteria

INLUSION CRITERIA Patients with a family history of hypertrophic cardiomyopathy are eligible.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, United StatesOpen National Heart, Lung and Blood Institute (NHLBI) in Google Maps
CompletedOne Study Center