CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 39 enrolled
Drug / intervention
Diltiazem +1 moredrug
Likely dose
Diltiazem 360 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00319982
NCT00319982Phase 3Completed

Treatment of Preclinical Hypertrophic Cardiomyopathy With Diltiazem

Brigham and Women's Hospital·interventional·Posted Apr 27, 2006·Updated Apr 7, 2015

In Brief

A Phase 3 clinical trial evaluating Diltiazem and Placebo for Hypertrophic Cardiomyopathy. Completed, enrolled 39 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 27, 2006
Enrollment StartJan 1, 2006
Primary CompletionDec 1, 2012
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 20.2 years ago

Interventions

Diltiazemdrug

Sustained release formulation titrated to a target dose of 360 mg daily, or a maximum of 5 mg/kg/day in pediatric subjects for the duration of the study period

Placebodrug

Placebo comparator (double-blind allocation of study medication)