Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001530
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: April 1999

November 3, 1999
March 3, 2008
April 1996
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Complete list of historical versions of study NCT00001530 on ClinicalTrials.gov Archive Site
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Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy
Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy

DDD pacing improves symptoms and relieves LV outflow tract (LVOT) obstruction in most patients with hypertrophic cardiomyopathy (HCM). Notably, when pacing is temporarily discontinued, the beneficial effects of pacing are evident in sinus rhythm. The long term results of this novel therapy are, however, uncertain. We propose (1) to record the hemodynamic changes following >4 years of pacing; and (2) to determine whether DDD pacing continues to be necessary in patients who have had a substantial relief of their LVOT obstruction. Patients who have had >50% reduction in LVOT pressure gradients will be randomized to two pacing modalities: DDD at 70 beats per minute and AAI pacing at 70 beats per minute (DDD switched off), and reevaluated after a six-month period.

DDD pacing improves symptoms and relieves LV outflow tract (LVOT) obstruction in most patients with hypertrophic cardiomyopathy (HCM). Notably, when pacing is temporarily discontinued, the beneficial effects of pacing are evident in sinus rhythm. The long term results of this novel therapy are, however, uncertain. We propose (1) to record the hemodynamic changes following >4 years of pacing; and (2) to determine whether DDD pacing continues to be necessary in patients who have had a substantial relief of their LVOT obstruction. Patients who have had >50% reduction in LVOT pressure gradients will be randomized to two pacing modalities: DDD at 70 beats per minute and AAI pacing at 70 beats per minute (DDD switched off), and reevaluated after a six-month period.

Observational
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Cardiomyopathy, Hypertrophic
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
May 2000
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Group 1:

HCM patients, aged grater than 20 years of either gender who received DDD pacemakers at the NIH at least 4 years ago, for relief of LVOT obstruction and drug-refractory symptoms.

Group 2:

HCM patients selected from Group 1 who at the follow-up cardiac catheterization are demonstrated to have either (1) no significant LVOT obstruction (less than 30mm HG at rest and less than 50mm HG with Isuprel); or (2) a substantial reduction of the LVOT obstruction (greater than 50% reduction in LVOT gradient).

Patient who have developed a heart block will be excluded from group 2.

Females must have a negative pregnancy test.

Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001530
960059, 96-H-0059
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National Heart, Lung, and Blood Institute (NHLBI)
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National Institutes of Health Clinical Center (CC)
April 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP