Congestive Heart FailurePhase 2NCT00032643
A Thyroid Hormone Analog to Fight Heart Failure: Phase II Trial (DITPA)
A Phase 2 study testing DITPA in people with Congestive Heart Failure, run by US Department of Veterans Affairs at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- DITPA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 7 sitesUnited States
- Study dates
- Jun 2004to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be enrolled, patients must:
- be veterans,
- have moderately severe CHF (NYHA class II, III or IV),
- be 18 or older,
- not have clinically important renal, hepatic or hematological disorders or clinically significant abnormal laboratory findings,
- not have a pre-existing thyroid disease,
Show all 23Show fewer
- not have anemia (hematocrit less than 30%),
- not have chronic pulmonary disease that limits exercise tolerance or requires use of chronic bronchodilator therapy or steroids,
- be able to walk on the level for 6 minutes,
- not have hemodynamically significant pericardial disease,
- not have angina pectoris severe enough to require frequent administration of sublingual nitroglycerin,
- not have acute myocardial infarction within 6 months of screening,
- not have inoperable aortic stenosis,
- not have symptomatic ventricular arrhythmias or ventricular arrhythmia requiring pharmacological therapy,
- not have implanted cardioverter defibrillator,
- not be taking amiodarone,
- not have demonstrated non-compliance with prior medical regimes;
- not be on an investigational drug,
- not have a medical condition that, in the investigator's opinion, would make the patient ineligible,
- not have an allergy to iodine or shellfish,
- not be in sinus rhythm,
- not be of childbearing potential,
- have an ejection fraction greater than 40%.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, 29401-5799
VA Medical Center, Cleveland
Cleveland, Ohio, 44106
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, 80220
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417
VA South Texas Health Care System, San Antonio
San Antonio, Texas, 78229
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073
About this study
Official title: CSP #526 - A Thyroid Hormone Analog to Fight Heart Failure: Phase II Trial (DITPA)
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. 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.
Read the 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 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.
- Conditions
- Congestive Heart Failure
- Being tested
- DITPA
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DITPADrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Drug: DITPA |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2002 (estimated)
- Study startJun 2004
- Primary completionDec 2006
- Study completionDec 2006
Why it stopped: Funding support withdrawn (much slower than expected enrollment)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Masking
- Double blind
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steven Goldman, MD, Study chair, Southern Arizona VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032643
- Sponsor's protocol ID
- 526
- Status last verified
- Nov 2013
- First submitted
- 27 Mar 2002
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #526 - A Thyroid Hormone Analog to Fight Heart Failure: Phase II Trial (DITPA)
- ClinicalTrials.gov ID
- NCT00032643
- Acronym / sponsor ID
- 526
- Conditions
- Congestive Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding support withdrawn (much slower than expected enrollment)
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jun 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 28 Mar 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
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 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.
Study design
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Drug: DITPA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- be veterans,
- have moderately severe CHF (NYHA class II, III or IV),
- be 18 or older,
- not have clinically important renal, hepatic or hematological disorders or clinically significant abnormal laboratory findings,
- not have a pre-existing thyroid disease,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DITPA | Drug | Arm 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Funding support withdrawn (much slower than expected enrollment)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Goldman, MD study chair
Southern Arizona VA Health Care System
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DITPA in people with Congestive Heart Failure, run by US Department of Veterans Affairs at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding support withdrawn (much slower than expected enrollment)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2013.