Study of DITPA in Patients With Congestive Heart Failure

NCT00103519 | Terminated Phase 2

• 1 other identifier: DIT-803
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 22

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. DITPA is an investigational agent.

Conditions

Heart Failure, Congestive

Keywords

Heart Failure, DITPA

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of DITPA

Secondary Outcomes (1)

• Efficacy of DITPA

Study Arms (3)

DITPA 180 mg/day

EXPERIMENTAL

DITPA 180 mg/day BID

Drug: DITPA (3,5-diiodothyropropionic acid)

DITPA 360 mg/day

EXPERIMENTAL

DITPA 360 mg/day BID

Drug: DITPA (3,5-diiodothyropropionic acid)

Placebo

PLACEBO COMPARATOR

Placebo BID

Drug: Placebo

Interventions

DITPA (3,5-diiodothyropropionic acid) DRUG

DITPA 180 mg/day; DITPA 360 mg/day

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Titan Pharmaceuticals: lead

Study Sites (22)

The Heart Center

Huntsville, Alabama, 35806, United States

Location

Cardiac Solutions

Peoria, Arizona, 85381, United States

Location

University of Arizona Sarver Heart Center

Tucson, Arizona, 85724, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Cardiovascular Consultants Medical Group

Walnut Creek, California, 94598, United States

Location

Saint Joseph's Research Institute

Atlanta, Georgia, 30342, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Louisiana State University Health Science Center

Shreveport, Louisiana, 71103, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Columbia University New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Cincinnati VA Medical Center

Cincinnati, Ohio, 45220, United States

Location

Clevaland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, 73120, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor University Medical Center Heart Place

Dallas, Texas, 75226, United States

Location

The University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

William S. Middleton Memorial Veterans Hospital

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

3,5-diiodothyropropionic acid

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Milton Packer, MD

  University of Texas Southwestern Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2005
• First Posted: February 10, 2005
• Study Start: December 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: March 29, 2013

Record last verified: 2006-11

Locations

US (22)