Treatment of Preclinical Hypertrophic Cardiomyopathy With Diltiazem
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Hypertrophic Cardiomyopathy
In brief
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.
Key facts
- Study ID
- NCT00319982
- Run by
- Brigham and Women's Hospital
- People needed
- 39
- Starts
- 2006-01-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2015-04-07
Who can join
Age: 5 and older, up to 39. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Preclinical HCM (identified sarcomere mutation with no clinical evidence of left ventricular hypertrophy)
- Able to provide informed consent (or parental consent)
You may not qualify if…
- Contraindication to diltiazem administration
- Impaired hepatic or renal function
- Age < 5 years
- Pregnant or breastfeeding women
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Children's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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