NCT00753233

Brief Summary

This study will review medical information collected on children and adolescents with hypertrophic cardiomyopathy (HCM) to try to identify risk factors for arrhythmias (abnormal heart rhythms) in these patients and better guide the choice of treatment options for them. Arrhythmias arising from the ventricle (lower heart chamber) can cause dizziness, fainting or cardiac arrest. Predictors of arrhythmias in adult HCM patients may not apply to children and teenagers with HCM. Children and adolescents 21 years of age or younger who were diagnosed with HCM and evaluated in the National Heart Lung and Blood Institute's Cardiology Branch between 1977 and 2002 may be eligible for this study. Participants do not undergo any further testing or data gathering beyond a review of their medical records; only existing data previously collected for research purposes are used. Medical records are reviewed for age of the patient on admission to the NIH; family history of sudden death, fainting, exercise-induced low blood pressure, and results of tests on heart structure and function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2008

Typical duration 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 5, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2008

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2012

Completed
Last Updated

July 2, 2017

Status Verified

January 25, 2012

First QC Date

September 12, 2008

Last Update Submit

June 30, 2017

Conditions

Keywords

Hypertrophic CardiomyopathyChildrenSudden DeathArrhythmiasElectrophysiology Study

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
* Children and adolescents (less than or equal to 21 years) with HCM who had been evaluated in the Cardiology Branch, National Heart Lung and Blood Institute between 1977 and 2002. HCM was diagnosed by echocardiographic demonstration of a hypertrophied non-dilated left ventricle (LV) in the absence of another cause of LV hypertrophy. All patients participated in protocols approved by the NHLBI Institutional Review Board, and provided informed written consent to participate. The patients participated in the following protocols: 98-H-0102, 77-H-0082, 99-H-0150, 01-H-0007, 96-H-0144, 94-H-0001, 84-H-0232, 98-H-0100, and 99-H-0065.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Colan SD, Lipshultz SE, Lowe AM, Sleeper LA, Messere J, Cox GF, Lurie PR, Orav EJ, Towbin JA. Epidemiology and cause-specific outcome of hypertrophic cardiomyopathy in children: findings from the Pediatric Cardiomyopathy Registry. Circulation. 2007 Feb 13;115(6):773-81. doi: 10.1161/CIRCULATIONAHA.106.621185. Epub 2007 Jan 29.

    PMID: 17261650BACKGROUND
  • Frenneaux MP. Assessing the risk of sudden cardiac death in a patient with hypertrophic cardiomyopathy. Heart. 2004 May;90(5):570-5. doi: 10.1136/hrt.2003.020529. No abstract available.

    PMID: 15084566BACKGROUND
  • Maron BJ, Shen WK, Link MS, Epstein AE, Almquist AK, Daubert JP, Bardy GH, Favale S, Rea RF, Boriani G, Estes NA 3rd, Spirito P. Efficacy of implantable cardioverter-defibrillators for the prevention of sudden death in patients with hypertrophic cardiomyopathy. N Engl J Med. 2000 Feb 10;342(6):365-73. doi: 10.1056/NEJM200002103420601.

    PMID: 10666426BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, HypertrophicDeath, SuddenArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

September 12, 2008

First Posted

September 16, 2008

Study Start

September 5, 2008

Study Completion

January 25, 2012

Last Updated

July 2, 2017

Record last verified: 2012-01-25

Locations