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

This study has been terminated.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00032643
First received: March 27, 2002
Last updated: January 20, 2009
Last verified: April 2008
History of Changes
  Purpose

Congestive heart failure (CHF) affects 4-5 million Americans, and its prevalence is predicted to increase over the next few decades. Thryoid 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.


Condition Intervention Phase
Congestive Heart Failure
 Drug: DITPA
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: CSP # - 526, A Thyroid Hormone Analog to Fight Heart Failure: Phase II Trial (DITPA)

Resource links provided by NLM:

Drug Information available for: Thyroid
U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 150
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032643

Locations
United States, Arizona
Tucson
Tucson, Arizona, United States, 85723
United States, California
West LA
Los Angeles, California, United States, 90073
United States, Colorado
Denver
Denver, Colorado, United States, 80220
United States, Minnesota
Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Ohio
Cleveland
Cleveland, Ohio, United States, 44106
United States, South Carolina
Charleston
Charleston, South Carolina, United States, 29401
United States, Texas
San Antonio
San Antonio, Texas, United States, 78284
Sponsors and Collaborators
Department of Veterans Affairs
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00032643     History of Changes
Other Study ID Numbers: 526
Study First Received: March 27, 2002
Last Updated: January 20, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013