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

Stopped early · Phase 2

Conditions studied: Congestive Heart Failure

In brief

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.

Key facts

Study ID

NCT00032643

Run by

US Department of Veterans Affairs

People needed

150

Starts

2004-06-01

Expected to finish

2006-12-01

Last updated by the study team

2013-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• INCLUSION
• To be enrolled, patients must:
• be veterans,
• have moderately severe CHF (NYHA class II, III or IV),
• be 18 or older,
• not have clinically important renal, hepatic or hematological disorders or clinically significant abnormal laboratory findings,
• not have a pre-existing thyroid disease,
• not have anemia (hematocrit less than 30%),
• not have chronic pulmonary disease that limits exercise tolerance or requires use of chronic bronchodilator therapy or steroids,
• be able to walk on the level for 6 minutes,
• not have hemodynamically significant pericardial disease,
• not have angina pectoris severe enough to require frequent administration of sublingual nitroglycerin,
• not have acute myocardial infarction within 6 months of screening,
• not have inoperable aortic stenosis,
• not have symptomatic ventricular arrhythmias or ventricular arrhythmia requiring pharmacological therapy,
• not have implanted cardioverter defibrillator,
• not be taking amiodarone,
• not have demonstrated non-compliance with prior medical regimes;
• not be on an investigational drug,
• not have a medical condition that, in the investigator's opinion, would make the patient ineligible,
• not have an allergy to iodine or shellfish,
• not be in sinus rhythm,
• not be of childbearing potential,
• have an ejection fraction greater than 40%.

Where it is running

• Southern Arizona VA Health Care System — Tucson, Arizona, United States
• VA Greater Los Angeles Healthcare System, West LA — West Los Angeles, California, United States
• VA Eastern Colorado Health Care System, Denver — Denver, Colorado, United States
• VA Medical Center, Minneapolis — Minneapolis, Minnesota, United States
• VA Medical Center, Cleveland — Cleveland, Ohio, United States
• Ralph H Johnson VA Medical Center, Charleston — Charleston, South Carolina, United States
• VA South Texas Health Care System, San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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