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(Circulation. 2009;119:3093-3100.)
© 2009 American Heart Association, Inc.

Heart Failure

DITPA (3,5-Diiodothyropropionic Acid), a Thyroid Hormone Analog to Treat Heart Failure

Phase II Trial Veterans Affairs Cooperative Study

Steven Goldman, MD^*; Madeline McCarren, PhD, MPH^*; Eugene Morkin, MD; Paul W. Ladenson, MD; Robert Edson, MA; Stuart Warren, JD, PharmD; Janet Ohm, MSN, RN; Hoang Thai, MD; Lori Churby, BA; Jamie Barnhill, PhD; Terrence O'Brien, MD; Inder Anand, MD; Alberta Warner, MD; Brack Hattler, MD; Mark Dunlap, MD; John Erikson, MD; Mei-Chiung Shih, PhD; Phil Lavori, PhD

From Cardiology, Southern Arizona VA Health Care System (S.G., J.O., H.T.), Tucson, Ariz; VA Pharmacy Benefits Management (M.M.), Hines, Ill; University of Arizona (E.M.), Tucson, Ariz; Johns Hopkins University (P.W.L.), Baltimore, Md; R&D Service (R.E., L.C., M.-C.S., P.L.), Veterans Affairs Medical Center, Palo Alto, Calif; R&D Service (S.W., J.B.), Veterans Affairs Medical Center, Albuquerque, NM; Cardiology (T.O.), Veterans Affairs Medical Center, Charleston, SC; Cardiology (I.A.), Veterans Affairs Medical Center, Minneapolis, Minn; Cardiology (A.W.), Veterans Affairs Medical Center, West Los Angeles, Calif; Cardiology (B.H.), Veterans Affairs Medical Center, Denver, Colo; Cardiology (M.D.), Veterans Affairs Medical Center, Cleveland, Ohio; and Cardiology (J.E.), Veterans Affairs Medical Center, San Antonio, Tex.

Correspondence to Steven Goldman, MD, Cardiology Section (1-111C), Southern Arizona VA Health Care System, 3601 S 6th Ave, Tucson, AZ 85723. E-mail steven.goldman{at}va.gov

Received November 14, 2008; accepted April 10, 2009.

Background— In animal studies and a pilot trial in patients with congestive heart failure, the thyroid hormone analog 3,5 diiodothyropropionic acid (DITPA) had beneficial hemodynamic effects.

Methods and Results— This was a phase II multicenter, randomized, placebo-controlled, double-blind trial of New York Heart Association class II to IV congestive heart failure patients randomized (2:1) to DITPA or placebo and treated for 6 months. The study enrolled 86 patients (n=57 to DITPA, n=29 to placebo). The primary objective was to assess the effect of DITPA on a composite congestive heart failure end point that classifies patients as improved, worsened, or unchanged based on symptom changes and morbidity/mortality. DITPA was poorly tolerated, which obscured the interpretation of congestive heart failure-specific effects. Fatigue and gastrointestinal complaints, in particular, were more frequent in the DITPA group. DITPA increased cardiac index (by 18%) and decreased systemic vascular resistance (by 11%), serum cholesterol (–20%), low-density lipoprotein cholesterol (–30%), and body weight (–11 lb). Thyroid-stimulating hormone was suppressed in patients given DITPA, which reflects its thyromimetic effect; however, no symptoms or signs of potential hypothyroidism or thyrotoxicosis were seen.

Conclusions— DITPA improved some hemodynamic and metabolic parameters, but there was no evidence for symptomatic benefit in congestive heart failure.

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CLINICAL PERSPECTIVE

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Circulation: Clinical Summaries
Circulation 2009 119: 3041-3043. [Extract] [Full Text]