CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 131 enrolled
Drug / intervention
Thiamine +1 moredrug
Likely dose
Thiamine 100 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/NCT00680706
NCT00680706Phase 2Completed

Targeting Myocardial Energy Metabolism for the Treatment of Acute Heart Failure: The Effect of Thiamine on Biochemical, Electrocardiographic and Respiratory Parameters in Hospitalized Patients.

Baystate Medical Center·interventional·Posted May 20, 2008·Updated Aug 21, 2013

In Brief

A Phase 2 clinical trial evaluating Thiamine and Placebo for Heart Failure and Diabetes. Completed, enrolled 131 participants across 2 sites.

Detailed 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.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 20, 2008
Enrollment StartJan 1, 2008
Primary CompletionFeb 1, 2010
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.1 years ago

Interventions

Thiaminedrug

Thiamine (100 mg) in 50 ml D5W, x 2.

Placebodrug

D5W (50 ml)