Study of DITPA in Patients With Congestive Heart Failure

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Heart Failure, Congestive

In brief

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.

Key facts

Study ID

NCT00103519

Run by

Titan Pharmaceuticals

People needed

86

Starts

2004-12-01

Expected to finish

2006-12-01

Last updated by the study team

2013-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Greater than or equal to 18 years of age
• NYHA class III or IV CHF
• Females must not be pregnant or lactating. Females of childbearing potential and males must use a reliable means of contraception
• Serum total T3 <= 95 ng/dL with normal levels of TSH
• On a regimen consisting of angiotensin-converting enzyme inhibitors and/or angiotensin receptor antagonists, beta blockers, and diuretics for a minimum of 3 months prior to randomization
• Clinically stable for 2 weeks prior to randomization (defined as no change in functional class by NYHA, no hospitalization or ER visit, and no intravenous inotropic or vasodilator treatment for 2 weeks)
• An LVEF <= 40%, documented within 6 months prior to randomization, or > 6 months with confirmation of LVEF by local echocardiographic measurements within 2 weeks prior to randomization
• Able to give informed consent

You may not qualify if…

• New onset CHF (less than 3 months prior to randomization)
• Active myocarditis, hypertrophic cardiomyopathy, uncorrected primary valvular disease, restrictive cardiomyopathy, uncorrected congenital heart disease, or constrictive pericarditis
• Myocardial infarction, unstable ischemic heart disease, stroke, or coronary revascularization procedure within 4 weeks prior to randomization; or an expectation of a coronary revascularization procedure, cardiac transplant, or left ventricular assist device placement being needed within 24 weeks after randomization
• History of sudden arrhythmic syncope or sustained ventricular arrhythmia, unless the patient has an implantable cardioverter defibrillator (ICD) for at least 12 weeks prior to randomization; history of clinically significant heart block, unless the patient has had a pacemaker at least 12 weeks prior to randomization
• History of cardiac resynchronization therapy in the last 12 weeks prior to randomization or expectation of cardiac resynchronization therapy or ventricular mechanical assistance needed within 24 weeks after randomization
• History of cardiac transplant
• Heart rate < 50 beats per minute or > 130 beats per minute
• Systolic blood pressure <= 80 mm Hg
• Serum creatinine => 2.5 mg/dL
• Treatment with intravenous vasodilators (including nesiritide) or inotropes within 2 weeks prior to randomization
• Receipt of any other investigational agent or device within 4 weeks prior to randomization
• Diagnosis of other non-cardiac underlying medical conditions expected to impact their mortality within 24 weeks after randomization
• Drug or alcohol dependence, or other conditions which may affect study compliance
• History of thyroid disorders of any form within 24 weeks prior to randomization
• Use of thyroid supplements (levothyroxine, liothyronine, etc.) or any preparation containing thyromimetic agents within 24 weeks prior to randomization
• Supraventricular arrhythmia refractory to conventional treatment, as judged by the investigators

Where it is running

• The Heart Center — Huntsville, Alabama, United States
• Cardiac Solutions — Peoria, Arizona, United States
• University of Arizona Sarver Heart Center — Tucson, Arizona, United States
• University of Southern California — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Cardiovascular Consultants Medical Group — Walnut Creek, California, United States
• Saint Joseph's Research Institute — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• Louisiana State University Health Science Center — Shreveport, Louisiana, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Columbia University New York Presbyterian Hospital — New York, New York, United States
• Cincinnati VA Medical Center — Cincinnati, Ohio, United States
• Clevaland Clinic Foundation — Cleveland, Ohio, United States
• Oklahoma Foundation for Cardiovascular Research — Oklahoma City, Oklahoma, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Baylor University Medical Center Heart Place — Dallas, Texas, United States
• The University of Virginia Health System — Charlottesville, Virginia, United States
• William S. Middleton Memorial Veterans Hospital — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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