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NCT00879060 · ClinicalTrials.gov registry record · Phase 4
Clinical and Therapeutic Implications of Fibrosis in Hypertrophic Cardiomyopathy
A Phase 4 study, sponsored by Tufts Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 53
- Enrollment target
NCT00879060: Completed Phase 4 study, sponsored by Tufts Medical Center.
NCT00879060 is a Phase 4 study that has completed, run by Tufts Medical Center. The registered enrollment target is 53 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00879060, a Phase 4 study, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 53 participants
- Enrollment target
Study Summary
Hypertrophic Cardiomyopathy (HCM) is the most common genetic cardiomyopathy and remains the leading cause of sudden cardiac death in young people and an important cause of heart failure symptoms and death at any age. In HCM, pathological remodeling of the left ventricle involving myocardial fibrosis is likely a major contributor to cardiac dysfunction and also a nidus for the generation of ventricular arrhythmias. Serum markers of collagen turnover have been shown to reliably reflect the magnitude of myocardial fibrosis in a variety of cardiovascular diseases. In addition, aldosterone antagonist drugs have been shown to decrease fibrous tissue formation in the myocardium in certain pathologic cardiovascular states in which aldosterone production is increased. In HCM, aldosterone production is up-regulated and has been implicated in the formation of myocardial fibrosis. Therefore, the specific aims of this proposal are to: 1. assess serum markers of collagen turnover at baseline and correlate these findings with a variety of clinical and morphologic disease parameters 2. examine the effects of a 12-month treatment with the aldosterone antagonist spironolactone on magnitude of fibrosis as measured by serum markers of collagen turnover as well as changes in clinical and morphologic disease parameters. 3. explore the effects of a 12-month treatment with aldosterone antagonist spironolactone on heart failure status, diastolic function, arrhythmic burden, and total LV mass and quantity of fibrosis by CMR. The results of this proposal will offer important insights into the clinical significance of myocardial fibrosis in this primary genetic cardiomyopathy. The demonstration that spironolactone decreases fibrosis and improves clinical course would provide the rational for a larger multicenter clinical trial evaluating this novel therapy for improving clinical outcome in patients with HCM.
Primary Outcome
Specific variables of collagen turnover markers that will be evaluated include markers of collagen synthesis (PINP, PIIINP), and marker of collagen degradation (ICTP). A two-sample t-test was used to compare the differences between these collagen turnover markers at baseline and the absolute differences in change from baseline to 12 months of follow-up.
Interventions
- DRUG Placebo
- DRUG Spironolactone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2007-11 |
| Est. Completion | 2012-11 |
| Phase | Phase 4 |
What the finished NCT00879060 record still lists
NCT00879060 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00879060 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00879060 about?
NCT00879060 is a clinical study titled "Clinical and Therapeutic Implications of Fibrosis in Hypertrophic Cardiomyopathy". Hypertrophic Cardiomyopathy (HCM) is the most common genetic cardiomyopathy and remains the leading cause of sudden cardiac death in young people and an important cause of heart failure symptoms and death at any age. In HCM, pathological remodeling of the left ventricle involving myocardial fibrosis...
What is the current status of trial NCT00879060?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 53 participants. The study started on 2007-11. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00879060?
The interventions under investigation include: Placebo (DRUG), Spironolactone (DRUG).
Who is sponsoring clinical trial NCT00879060?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00879060's enrollment target sits among peer trials
53 1229th of 2000 higher than 768 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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