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NCT00680706 · ClinicalTrials.gov registry record · Phase 2
Thiamine and Acute Decompensated Heart Failure: Pilot Study
A Phase 2 study, sponsored by Baystate Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
NCT00680706 is a Phase 2 study that has completed, run by Baystate Medical Center. The registered enrollment target is 131 participants.
The verdict
NCT00680706, a Phase 2 study, has completed, sponsored by Baystate Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
Study Summary
Heart failure remains an increasing cause of morbidity and mortality in the United States even in the face of recent advances in the treatment of cardiovascular disease. There is an urgent need to reevaluate the treatment of heart failure. Shifting substrate utilization used in energy metabolism from fatty acids to glucose is beneficial to the heart presumably by increasing the efficiency of ATP production. Several new drugs for the treatment of cardiac ischemia work by this mechanism. There is increasing evidence that patients with heart failure may also benefit by the same type of intervention. Patients with heart failure are known to have low serum thiamine levels because of poor dietary intake and increased urinary excretion. Inadequate thiamine will deleteriously shift substrate utilization from glucose to fatty acids. We hypothesize that thiamine supplementation will be beneficial for patients with heart failure by increasing glucose and decreasing fatty acid utilization. This will be initially tested in a pilot double-blinded placebo controlled study of thiamine supplementation in diabetic and non-diabetic patients presenting to the emergency department with acute decompensated heart failure.
Interventions
- DRUG Placebo
- DRUG Thiamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2008-01 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00680706
The ClinicalTrials.gov registry entry for NCT00680706 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baystate Medical Center, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00680706 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00680706 about?
NCT00680706 is a clinical study titled "Thiamine and Acute Decompensated Heart Failure: Pilot Study". Heart failure remains an increasing cause of morbidity and mortality in the United States even in the face of recent advances in the treatment of cardiovascular disease. There is an urgent need to reevaluate the treatment of heart failure. Shifting substrate utilization used in energy metabolism fro...
What is the current status of trial NCT00680706?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2008-01. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00680706?
The interventions under investigation include: Placebo (DRUG), Thiamine (DRUG).
Who is sponsoring clinical trial NCT00680706?
This trial is sponsored by Baystate Medical Center, which has 36 total clinical trials registered on ClinicalTrials.gov.
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