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A Thyroid Hormone Analog to Fight Heart Failure: Phase II Trial (DITPA)

NCT00032643 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2013-11-05

No results posted yet for this study

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.

Conditions

  • Congestive Heart Failure

Interventions

DRUG

DITPA

Sponsors & Collaborators

Principal Investigators

  • Steven Goldman, MD · Southern Arizona VA Health Care System

Study Design

Masking
DOUBLE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00032643 on ClinicalTrials.gov