Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy of Children With Obstructive Hypertrophic Cardiomyop...

NCT00001396 | Completed Phase 1

• 2 other identifiers: 94000194-H-0001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Several studies have shown that specialized pacemaking devices (DDD pacing) can improve the symptoms associated with hypertrophic cardiomyopathy (HCM) in adults. In addition, studies have also shown that specialized pacemaking devices (DDD pacing) can improve conditions of HCM in children. However, growth of the body and organs, including the heart, is very rapid during childhood. Therefore the long-term effects of DDD pacing in children are unknown. The purpose of this study is to examine the growth rate and nutrition of children with HCM. Due to this heart condition and the restrictions that are often placed on the child's activity level, children with HCM may grow at a slower rat and may have a greater tendency to be overweight. Children participating in the study will have their growth rate and nutritional status measured before the study begins and throughout the course of the study. Findings in this research study will not directly benefit the patients participating in it. However, information gathered as a result of this study may lead to improvements in the management of children with HCM in the future.

Conditions

Hypertrophic Cardiomyopathy

Keywords

Pacemaker; Pediatric; Obstructive HCM

Interventions

Paragon Pacemaker DEVICE

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children of either gender, aged 5 to 15 years.
• Presence of LV hypertrophy and LV outflow obstruction.

You may not qualify if:

• Other systemic disease that prevent evaluation by echocardiography or cardiac catheterization.
• Chronic atrial fibrillation.
• Positive pregnancy test.
• Children of either gender, 5 to 20 years (children greater than 15 years will be included if there is access to reliable previous catheterization data).
• Presence of LV hypertrophy and LV obstruction.
• Other systemic disease that prevent evaluation by echocardiography or cardiac catheterization.
• Chronic atrial fibrillation.
• Positive pregnancy test.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Fananapazir L, Cannon RO 3rd, Tripodi D, Panza JA. Impact of dual-chamber permanent pacing in patients with obstructive hypertrophic cardiomyopathy with symptoms refractory to verapamil and beta-adrenergic blocker therapy. Circulation. 1992 Jun;85(6):2149-61. doi: 10.1161/01.cir.85.6.2149.

  PMID: 1350522 BACKGROUND

• Slade AK, Sadoul N, Shapiro L, Chojnowska L, Simon JP, Saumarez RC, Dodinot B, Camm AJ, McKenna WJ, Aliot E. DDD pacing in hypertrophic cardiomyopathy: a multicentre clinical experience. Heart. 1996 Jan;75(1):44-9. doi: 10.1136/hrt.75.1.44.

  PMID: 8624871 BACKGROUND

• McAreavey D, Fananapazir L. Altered cardiac hemodynamic and electrical state in normal sinus rhythm after chronic dual-chamber pacing for relief of left ventricular outflow obstruction in hypertrophic cardiomyopathy. Am J Cardiol. 1992 Sep 1;70(6):651-6. doi: 10.1016/0002-9149(92)90207-f.

  PMID: 1510015 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: October 6, 1993
• Study Completion: July 23, 2008
• Last Updated: July 2, 2017

Record last verified: 2008-07-23

Locations

US (1)