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

November 4, 2013 updated by: US Department of Veterans Affairs

CSP #526 - A Thyroid Hormone Analog to Fight Heart Failure: Phase II Trial (DITPA)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Intervention: After enrollment, patients receive a clinical assessment, echocardiogram and laboratory studies. Then, each patient receives treatment with one of two doses of 3,5-diiodothyropropionic acid (DITPA) or placebo for six months.

Primary hypothesis: DITPA will improve cardiovascular function and clinical status in patients with moderately severe heart failure and be similar to placebo on safety measures.

Secondary hypothesis:

Primary Outcomes: 1. Composite endpoint composed of cardiovascular mortality/morbidity, change in NYHA class and change in global assessment, and 2. safety.

Study Abstract: 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 effects of thyroid hormone, there is interest in developing analogs with fewer undesirable side effects. 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 define the dose of DITPA needed to achieve hemodynamic improvement 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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Health Care System
    • California
      • West Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System, West LA
    • Colorado
      • Denver, Colorado, United States, 80220
        • VA Eastern Colorado Health Care System, Denver
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • VA Medical Center, Minneapolis
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • VA Medical Center, Cleveland
    • South Carolina
      • Charleston, South Carolina, United States, 29401-5799
        • Ralph H Johnson VA Medical Center, Charleston
    • Texas
      • San Antonio, Texas, United States, 78229
        • VA South Texas Health Care System, San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

INCLUSION

To be enrolled, patients must:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Drug: DITPA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Study Chair: Steven Goldman, MD, Southern Arizona VA Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

March 27, 2002

First Submitted That Met QC Criteria

March 27, 2002

First Posted (Estimate)

March 28, 2002

Study Record Updates

Last Update Posted (Estimate)

November 5, 2013

Last Update Submitted That Met QC Criteria

November 4, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 526

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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