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NCT00319982 · ClinicalTrials.gov registry record · Phase 2
Treatment of Preclinical Hypertrophic Cardiomyopathy With Diltiazem
A Phase 2 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT00319982 is a Phase 2 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 39 participants.
The verdict
NCT00319982, a Phase 2 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Diltiazem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2006-01 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00319982
The ClinicalTrials.gov registry entry for NCT00319982 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00319982 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00319982 about?
NCT00319982 is a clinical study titled "Treatment of Preclinical Hypertrophic Cardiomyopathy With Diltiazem". 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 ...
What is the current status of trial NCT00319982?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2006-01. Estimated completion is 2013-12.
What interventions are being tested in trial NCT00319982?
The interventions under investigation include: Placebo (DRUG), Diltiazem (DRUG).
Who is sponsoring clinical trial NCT00319982?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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