Status:
TERMINATED
Study of DITPA in Patients With Congestive Heart Failure
Lead Sponsor:
Titan Pharmaceuticals
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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. DIT...
Detailed Description
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 diseas...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00103519
Start Date
December 1 2004
End Date
December 1 2006
Last Update
March 29 2013
Active Locations (22)
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1
The Heart Center
Huntsville, Alabama, United States, 35806
2
Cardiac Solutions
Peoria, Arizona, United States, 85381
3
University of Arizona Sarver Heart Center
Tucson, Arizona, United States, 85724
4
University of Southern California
Los Angeles, California, United States, 90033