Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032643
Status:
TERMINATED
Last Update Posted:
2013-11-05
First Post:
2002-03-27
Brief Title:
A Thyroid Hormone Analog to Fight Heart Failure Phase II Trial DITPA
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 526 - A Thyroid Hormone Analog to Fight Heart Failure Phase II Trial DITPA
Status:
TERMINATED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding support withdrawn much slower than expected enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 affects of thyroid hormone there is interest in developing analogs with fewer undesirable side effects 35- 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
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
Detailed Description:
Intervention After enrollment patients receive a clinical assessment echocardiogram and laboratory studies Then each patient receives treatment with one of two doses of 35-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 mortalitymorbidity 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
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 mortalitymorbidity 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None