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

NCT00032643 | Terminated Phase 2

• 1 other identifier: 526
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

Brief 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

Study Arms (1)

Arm 1

OTHER

Drug: DITPA

Interventions

DITPA DRUG

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (7)

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

Location

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

Location

VA Medical Center, Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

Ralph H Johnson VA Medical Center, Charleston

Charleston, South Carolina, 29401-5799, United States

Location

VA South Texas Health Care System, San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Steven Goldman, MD

  Southern Arizona VA Health Care System

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2002
• First Posted: March 28, 2002
• Study Start: June 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

US (7)