NCT00001632

Brief Summary

The human heart is divided into four chambers. One of the four chambers, the left ventricle, is the chamber mainly responsible for pumping blood out of the heart into the circulation. Hypertrophic cardiomyopathy is a genetically inherited disease causing an abnormal thickening of heart muscle, especially the muscle making up the left ventricle. When the left ventricle becomes abnormally large, it is called left ventricular hypertrophy (LVH). Patients with HCM can be born with an enlarged left ventricle or they may develop the condition in childhood or adolescence, usually during the time when the body is rapidly growing. However, not all patients with the abnormal genes linked to HCM have the characteristic LVH. Currently, it is impossible to tell if a patient with the genes for HCM will develop LVH. A recently developed ultrasound tool called an integrated backscatter analysis (IBS), may allow researchers to determine those children who may later develop HCM and LVH. In order to test this, researchers plan to use IBS to study normal children with relatives diagnosed with HCM. This study will compare the results of IBS done on normal children with relatives diagnosed with HCM , normal children, and children with evidence enlarged heart muscle (HCM).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
Last Updated

March 4, 2008

Status Verified

August 1, 2002

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

HypertrophyIntegratedBackscatterCyclicEchocardiographyHypertrophic Cardiomyopathy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Three groups of subjects (aged 1-15 years) will be studied: normal children, children with HCM, and children that are family members of patients with HCM, but do not themselves have any evidence of LVH.
  • CONTROL GROUP (NORM GROUP):
  • Normal children under the age of 15 who have a normal two-dimensional echocardiogram will be included in the study.
  • HYPERTROPHIC CARDIOMYOPATHY GROUP (HCM GROUP):
  • Patients with HCM (unexplained LVH on two-dimensional echocardiogram) under the age of 15 will be included.
  • Family History of Hypertrophic Cardiomyopathy Group (FHCM GROUP:
  • Normal children under the age of 15 who have a first-degree relative with HCM and a normal two-dimensional echocardiogram will be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Panza JA, Maron BJ. Relation of electrocardiographic abnormalities to evolving left ventricular hypertrophy in hypertrophic cardiomyopathy during childhood. Am J Cardiol. 1989 May 15;63(17):1258-65. doi: 10.1016/0002-9149(89)90187-2.

    PMID: 2523641BACKGROUND
  • Miller JG, Perez JE, Sobel BE. Ultrasonic characterization of myocardium. Prog Cardiovasc Dis. 1985 Sep-Oct;28(2):85-110. doi: 10.1016/0033-0620(85)90020-9. No abstract available.

    PMID: 3898225BACKGROUND
  • Vitale DF, Bonow RO, Calabro R, De Cristofaro M, Pacileo G, Caso P, Gerundo G, Bordini C, Losi MA, Rengo C, Rengo F. Myocardial ultrasonic tissue characterization in pediatric and adult patients with hypertrophic cardiomyopathy. Circulation. 1996 Dec 1;94(11):2826-30. doi: 10.1161/01.cir.94.11.2826.

    PMID: 8941108BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, HypertrophicHypertrophy, Left VentricularHypertrophy

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesCardiomegalyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

September 1, 1997

Study Completion

August 1, 2002

Last Updated

March 4, 2008

Record last verified: 2002-08

Locations