Phase 3
N=39
Treatment of Preclinical Hypertrophic Cardiomyopathy With Diltiazem
Hypertrophic Cardiomyopathy
Bottom Line
View on ClinicalTrials.gov: NCT00319982 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Increase, Stability of, or Decrease in the Decline of Diastolic Function as Reflected by the Global Early Myocardial Relaxation (E') Velocity — -0.06; -0.21 cm/sec (difference final-baseline) — p=0.75
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Diltiazem (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Increase, Stability of, or Decrease in the Decline of Diastolic Function as Reflected by the Global Early Myocardial Relaxation (E') Velocity |
-0.06; -0.21 | 0.75 |
| SECONDARY Safety and Tolerability of Diltiazem Treatment |
10; 12 | 0.99 |
| SECONDARY Impact of Diltiazem on Heart Rate |
-4.9; 2.0 | >0.06 |
| SECONDARY Left Ventricular Cavity Size |
0.60; -0.53 | <0.001 sig |
| SECONDARY Development of Left Ventricular Hypertrophy |
2; 2 | — |
| SECONDARY Adherence to Study Medication |
83; 90 | 0.08 |
| SECONDARY Impact of Diltiazem on Systolic Blood Pressure |
-1.4; 2.1 | 0.15 |
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.
Eligibility Criteria
Inclusion Criteria
- Preclinical HCM (identified sarcomere mutation with no clinical evidence of left ventricular hypertrophy)
- Able to provide informed consent (or parental consent)
Exclusion Criteria
- Contraindication to diltiazem administration
- Impaired hepatic or renal function
- Age < 5 years
- Pregnant or breastfeeding women
Data sourced from ClinicalTrials.gov (NCT00319982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.