Treatment of Preclinical Hypertrophic Cardiomyopathy With Diltiazem
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
This is a pilot clinical trial to assess whether the administration of diltiazem may be able
to decrease the development or progression of hypertrophic cardiomyopathy (HCM). Diltiazem is
a commonly used medication for the treatment of high blood pressure and studies on animals
with HCM suggest that diltiazem decreases disease development. This study specifically
targets individuals in the "prehypertrophic" phase of HCM-- those with documented sarcomere
gene mutations without echocardiographic or EKG evidence of LVH, and therefore without a
clinical diagnosis of HCM.
The hypothesis of this study is that starting diltiazem administration early in life (in the
prehypertrophic phase) will decrease the progression of HCM in individuals with sarcomere
gene mutations. This will be assessed by looking at an improvement in the heart's ability to
relax using echocardiography, as well as exploratory analyses of a broad range of features
reflecting the heart's structure and function.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Brigham and Women's Hospital
Collaborators:
Boston Children's Hospital Boston Children’s Hospital National Heart, Lung, and Blood Institute (NHLBI)