A Thyroid Hormone Analog to Fight Heart Failure: Phase II Trial (DITPA)
Status:
Terminated
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
Congestive heart failure (CHF) affects 4-5 million Americans, and its prevalence is predicted
to increase over the next few decades. Thyroid hormone has unique actions which make it a
novel and potentially useful agent for treatment of CHF. Due to possible adverse affects of
thyroid hormone, there is interest in developing analogs with fewer undesirable side effects.
3,5- diiodothyropropionic acid (DITPA) has been shown to improve diastolic function in both
animal models and a recently completed double-blind placebo controlled trial in 19 humans.
The goal of the proposed Phase II study is to show safety and demonstrate a medication of
efficacy of DITPA needed in patients with CHF. This study is a prerequisite for a larger
Phase III trial which would determine whether mortality is improved with DITPA. To better
define the appropriate doses, prior to the Phase II study we will conduct an initial
pharmacokinetic study.
Phase:
Phase 2
Details
Lead Sponsor:
US Department of Veterans Affairs VA Office of Research and Development