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Home > "L" Clinical Trials Conditions > Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy  Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy
Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy
For Condition: Cardiomyopathy, Hypertrophic
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 120
Location and Contact Information:
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 960059; 96-H-0059
Study Start Date: April 8, 1996
Record last reviewed: April 21, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001530
Other Cardiomyopathy, Hypertrophic Studies:
1. Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy
2. Analysis of Heart Muscle Function in Patients with Heart Disease and Normal Volunteers
3. The Role of Heart Stiff and Weak Atrium on Exercise Capacity in Patients with Hypertrophic Cardiomyopathy
4. Cyclosporine A to Treat Hypertrophic Cardiomyopathy (HCM)
Related Studies:
Other Cardiomyopathy, Hypertrophic Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy
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