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DITPA, A Thyroid Hormone Analog to Treat Heart Failure Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on DITPA, A Thyroid Hormone Analog to Treat Heart Failure conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. DITPA, A Thyroid Hormone Analog to Treat Heart Failure Clinical research trials and DITPA, A Thyroid Hormone Analog to Treat Heart Failure health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including DITPA, A Thyroid Hormone Analog to Treat Heart Failure. DITPA, A Thyroid Hormone Analog to Treat Heart Failure Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a DITPA, A Thyroid Hormone Analog to Treat Heart Failure clinical trial. Participants oftentimes recieve the most expert healthcare available for their DITPA, A Thyroid Hormone Analog to Treat Heart Failure condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > DITPA, A Thyroid Hormone Analog to Treat Heart Failure  DITPA, A Thyroid Hormone Analog to Treat Heart Failure
DITPA, A Thyroid Hormone Analog to Treat Heart Failure
For Condition: Congestive Heart Failure
Status: Not yet recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program
Synopsis: Congestive heart failure (CHF) affects 4-5 million Americans, and its prevalence is predicted to increase over the next few decades. Thryoid hormone has unique actions which make it a novel and potentially useful agent for treatment of CHF. Due to possible adverse affects of thyroid hormone, there is interest in developing analogs with fewer undesirable side effects. 3,5- diiodothyropropionic acid (DITPA) has been shown to improve diastolic function in both animal models and a recently completed double-blind placebo controlled trial in 19 humans. The goal of the proposed Phase II study is to show safety and demonstrate a medication of efficacy of DITPA needed in patients with CHF. This study is a prerequisite for a larger Phase III trial which would determine whether mortality is improved with DITPA. To better define the appropriate doses, prior to the Phase II study we will conduct an initial pharmacokinetic study.
Details: Intervention: After enrollment, patients receive a clinical assessment, echocardiogram and laboratory studies. Then, each patient receives treatment with one of two doses of 3,5-diiodothyropropionic acid (DITPA) or placebo for six months. Primary hypothesis: DITPA will improve cardiovascular function and clinical status in patients with moderately severe heart failure and be similar to placebo on safety measures. Secondary hypothesis: Primary Outcomes: 1. Composite endpoint composed of cardiovascular mortality/morbidity, change in NYHA class and change in global assessment, and 2. safety. Study Abstract: Congestive heart failure (CHF) affects 4-5 million Americans, and its prevalence is predicted to increase over the next few decades. Thyroid hormone has unique actions which make it a novel and potentially useful agent for treatment of CHF. Due to possible adverse effects of thyroid hormone, there is interest in developing analogs with fewer undesirable side effects. DITPA has been shown to improve diastolic function in both animal models and a recently completed double-blind placebo controlled trial in 19 humans. The goal of the proposed Phase II study is to define the dose of DITPA needed to achieve hemodynamic improvement in patients with CHF. This study is a prerequisite for a larger Phase III trial which would determine whether mortality is improved with DITPA. To better define the appropriate doses, prior to the Phase II study we will conduct an initial pharmacokinetic study.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: To be enrolled, patients must: 1) be veterans, 2) have moderately severe CHF (NYHA class II, III or IV), 3) be 18 or older, 4) not have clinically important renal, hepatic or hematological disorders or clinically significant abnormal laboratory findings, 5) not have a pre-existing thyroid disease, 6) not have anemia (hematocrit less than 30%), 7) not have chronic pulmonary disease that limits exercise tolerance or requires use of chronic bronchdilator therapy or steroids, 8) be able to walk on the level for 6 minutes, 9) not have hemodynamically significant pericardial disease, 10) not hve angina pectoris severe enough to require frequent administration of sublingual nitroglycerin, 11) not have acute myocardial infarction within 6 months of screening, 12) not have inoperable aortic stenosis, 13) not have symptomatic ventricular arrhythmias or ventricular arrhythmia requiring pharmacological therapy, 14) not have implanted cardioverter defibrillator, 15) not be taking amiodarone, 16) not have demonstrated non-compliance with prior medical regimes; 17) not be on an investigational drug, 18) not have a medical condition that, in the investigator's opinion, would make the patient ineligible, 19) not have an allergy to iodine or shellfish, 20) not be in sinus rhythm, 21) not be of childbearing potential, 22) have an ejection fraction greater than 40%.
Total Enrollment: 150
Location and Contact Information:
Additional Information:
Study ID Numbers: 526;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032643
Other Congestive Heart Failure Studies:
1. MYOHEARTâ„¢ (Myogenesis Heart Efficiency and Regeneration Trial)
2. Eplerenone on Cardiac Remodeling in Patients with Left Ventricular Systolic Dysfunction and Mild to Moderate Heart Failure
3. Safety and Efficacy Study of carvedilol to treat children with congestive heart failure
4. Safety and efficacy study of the vasopressin receptor antagonist conivaptan in patients with acute decompensated heart failure
5. DITPA, A Thyroid Hormone Analog to Treat Heart Failure
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DITPA, A Thyroid Hormone Analog to Treat Heart Failure
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