Study of DITPA in Patients With Congestive Heart Failure
This study will assess the safety and efficacy of DITPA relative to placebo in patients with New York Heart Association (NYHA) class III or IV congestive heart failure (CHF) who have low serum T3. DITPA is an investigational agent.
Rationale: Congestive heart failure (CHF) is a major public health problem associated with significant morbidity and mortality in patients with New York Heart Association (NYHA) class III or IV disease. Multiple studies have identified a particularly high-risk group of patients who have reduced thyroid hormone activity, specifically, low serum triiodothyronine (T3) levels. This group represents approximately 30% of patients with NYHA class III or IV disease and has significantly higher mortality rates than those with normal T3.
DITPA (3,5-diiodothyropropionic acid) is an analogue of naturally occurring thyroid hormone (T3) that has been specifically designed to improve cardiac performance with a lower potential for tachycardia in CHF patients. Although structurally similar to T3, DITPA has a propionic acid side chain and lacks an iodine at the 3' position of the outer phenolic ring. While DITPA binds to the same thyroid hormone receptors as T3, binding affinities are significantly less, suggesting partial agonistic actions. Preclinical studies with DITPA have supported a rationale for its use in patients with CHF.
Primary objective: To assess the safety and tolerability of DITPA in patients with NYHA class III/IV CHF and low serum T3.
Secondary Objective: To obtain preliminary evidence of the efficacy of DITPA in patients with NYHA class III/IV CHF and low serum T3
Design: The multi-center, randomized, double-blind, placebo-controlled study is designed to evaluate the safety and tolerability of DITPA in patients with NYHA class III or IV CHF who have low levels of serum T3 with normal levels of thyroid stimulating hormone (TSH).
One hundred and fifty patients at approximately 35 centers in the U.S. will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio (i.e., 50 patients per treatment group):
- DITPA at 180 mg/day (90 mg twice a day [BID], orally)
- DITPA at 360 mg/day (180 mg BID, orally)
- Placebo BID, orally
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Heart Failure, Congestive
DITPA (3,5-diiodothyropropionic acid)
The Heart Center
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00103519
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)
Agents that have a strengthening effect on the heart or that can increase cardiac output. They may be CARDIAC GLYCOSIDES; SYMPATHOMIMETICS; or other drugs. They are used after MYOCARDIAL INFARCT; CARDIAC SURGICAL PROCEDURES; in SHOCK; or in congestive heart failure (HEART FAILURE).
A semisynthetic digitalis glycoside with the general properties of DIGOXIN but more rapid onset of action. Its cardiotonic action is prolonged by its demethylation to DIGOXIN in the liver. It has been used in the treatment of congestive heart failure (HEART FAILURE).
A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.
Disease of CARDIAC MUSCLE resulting from chronic excessive alcohol consumption. Myocardial damage can be caused by: (1) a toxic effect of alcohol; (2) malnutrition in alcoholics such as THIAMINE DEFICIENCY; or (3) toxic effect of additives in alcoholic beverages such as COBALT. This disease is usually manifested by DYSPNEA and palpitations with CARDIOMEGALY and congestive heart failure (HEART FAILURE).
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