Functional assessment of patients treated with permanent dual chamber pacing as a primary treatment for hypertrophic cardiomyopathy.
K McDonald, E McWilliams, B O'Keeffe...
https://pubmed.ncbi.nlm.nih.gov/3181176Completed
All Genders
ID00001530
Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2008-03-04
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892
Status Unknown
Loading map...
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Impact of dual-chamber permanent pacing in patients with obstructive hypertrophic cardiomyopathy with symptoms refractory to verapamil and beta-adrenergic blocker therapy.
L Fananapazir, R O Cannon, D Tripodi...
https://pubmed.ncbi.nlm.nih.gov/1350522Long-term results of dual-chamber (DDD) pacing in obstructive hypertrophic cardiomyopathy. Evidence for progressive symptomatic and hemodynamic improvement and reduction of left ventricular hypertrophy.
L Fananapazir, N D Epstein, R V Curiel...
https://pubmed.ncbi.nlm.nih.gov/7994815