Heart Failure, CongestivePhase 2NCT00103519
Study of DITPA in Patients With Congestive Heart Failure
A Phase 2 study testing DITPA (3,5-diiodothyropropionic acid) in people with Heart Failure, Congestive, run by Titan Pharmaceuticals at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- DITPA (3,5-diiodothyropropionic acid)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 22 sitesUnited States
- Study dates
- Dec 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
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Saint Joseph's Research Institute
Atlanta, Georgia, 30342
The University of Virginia Health System
Charlottesville, Virginia, 22908
Rush University Medical Center
Chicago, Illinois, 60612
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220
Clevaland Clinic Foundation
Cleveland, Ohio, 44195
Baylor University Medical Center Heart Place
Dallas, Texas, 75226
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
The Heart Center
Huntsville, Alabama, 35806
University of Southern California
Los Angeles, California, 90033
UCLA Medical Center
Los Angeles, California, 90095
University of Louisville
Louisville, Kentucky, 40202
William S. Middleton Memorial Veterans Hospital
Madison, Wisconsin, 53705
Columbia University New York Presbyterian Hospital
New York, New York, 10032
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73120
Cardiac Solutions
Peoria, Arizona, 85381
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Oregon Health Sciences University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
University of California, San Francisco
San Francisco, California, 94143
Louisiana State University Health Science Center
Shreveport, Louisiana, 71103
University of Arizona Sarver Heart Center
Tucson, Arizona, 85724
Cardiovascular Consultants Medical Group
Walnut Creek, California, 94598
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of DITPA in Patients With NYHA Class III and IV Congestive Heart Failure Who Have Low Serum T3 Levels
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.
Read the 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 disease. Multiple studies have identified a particularly high-risk group of patients who have reduced thyroid hormone activity, specifically, low serum triiodothyronine (T3) levels. This group represents approximately 30% of patients with NYHA class III or IV disease and has significantly higher mortality rates than those with normal T3.
DITPA (3,5-diiodothyropropionic acid) is an analogue of naturally occurring thyroid hormone (T3) that has been specifically designed to improve cardiac performance with a lower potential for tachycardia in CHF patients. Although structurally similar to T3, DITPA has a propionic acid side chain and lacks an iodine at the 3' position of the outer phenolic ring. While DITPA binds to the same thyroid hormone receptors as T3, binding affinities are significantly less, suggesting partial agonistic actions. Preclinical studies with DITPA have supported a rationale for its use in patients with CHF.
Primary objective: To assess the safety and tolerability of DITPA in patients with NYHA class III/IV CHF and low serum T3.
Secondary Objective: To obtain preliminary evidence of the efficacy of DITPA in patients with NYHA class III/IV CHF and low serum T3
Design: The multi-center, randomized, double-blind, placebo-controlled study is designed to evaluate the safety and tolerability of DITPA in patients with NYHA class III or IV CHF who have low levels of serum T3 with normal levels of thyroid stimulating hormone (TSH).
One hundred and fifty patients at approximately 35 centers in the U.S. will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio (i.e., 50 patients per treatment group):
- DITPA at 180 mg/day (90 mg twice a day [BID], orally)
- DITPA at 360 mg/day (180 mg BID, orally)
- Placebo BID, orally
- Conditions
- Heart Failure, Congestive
- Being tested
- DITPA (3,5-diiodothyropropionic acid), Placebo
- Keywords
- Heart Failure, 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.
DITPA (3,5-diiodothyropropionic acid)Drug
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| DITPA 180 mg/day | Experimental | DITPA 180 mg/day BID Receives: Drug: DITPA (3,5-diiodothyropropionic acid) |
| DITPA 360 mg/day | Experimental | DITPA 360 mg/day BID Receives: Drug: DITPA (3,5-diiodothyropropionic acid) |
| Placebo | Placebo comparator | Placebo BID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of DITPA
Secondary outcomes (1)
Efficacy of DITPA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2005 (estimated)
- Study startDec 2004
- Primary completionDec 2006
- Study completionDec 2006
Why it stopped: Study terminated for reasons unrelated to safety or efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Titan Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Milton Packer, MD, Study chair, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103519
- Sponsor's protocol ID
- DIT-803
- Status last verified
- Nov 2006
- First submitted
- 9 Feb 2005
- Last updated
- 29 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of DITPA in Patients With NYHA Class III and IV Congestive Heart Failure Who Have Low Serum T3 Levels
- ClinicalTrials.gov ID
- NCT00103519
- Acronym / sponsor ID
- DIT-803
- Conditions
- Heart Failure, Congestive
- Keywords
- Heart Failure, DITPA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated for reasons unrelated to safety or efficacy.
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Titan PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 10 Feb 2005 (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.
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.
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 disease. Multiple studies have identified a particularly high-risk group of patients who have reduced thyroid hormone activity, specifically, low serum triiodothyronine (T3) levels. This group represents approximately 30% of patients with NYHA class III or IV disease and has significantly higher mortality rates than those with normal T3.
DITPA (3,5-diiodothyropropionic acid) is an analogue of naturally occurring thyroid hormone (T3) that has been specifically designed to improve cardiac performance with a lower potential for tachycardia in CHF patients. Although structurally similar to T3, DITPA has a propionic acid side chain and lacks an iodine at the 3' position of the outer phenolic ring. While DITPA binds to the same thyroid hormone receptors as T3, binding affinities are significantly less, suggesting partial agonistic actions. Preclinical studies with DITPA have supported a rationale for its use in patients with CHF.
Primary objective: To assess the safety and tolerability of DITPA in patients with NYHA class III/IV CHF and low serum T3.
Secondary Objective: To obtain preliminary evidence of the efficacy of DITPA in patients with NYHA class III/IV CHF and low serum T3
Design: The multi-center, randomized, double-blind, placebo-controlled study is designed to evaluate the safety and tolerability of DITPA in patients with NYHA class III or IV CHF who have low levels of serum T3 with normal levels of thyroid stimulating hormone (TSH).
One hundred and fifty patients at approximately 35 centers in the U.S. will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio (i.e., 50 patients per treatment group):
- DITPA at 180 mg/day (90 mg twice a day [BID], orally)
- DITPA at 360 mg/day (180 mg BID, orally)
- Placebo BID, orally
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DITPA 180 mg/day | Experimental | Drug: DITPA (3,5-diiodothyropropionic acid)DITPA 180 mg/day BID |
| DITPA 360 mg/day | Experimental | Drug: DITPA (3,5-diiodothyropropionic acid)DITPA 360 mg/day BID |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 (3,5-diiodothyropropionic acid) | Drug | DITPA 180 mg/day, DITPA 360 mg/day |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Safety and tolerability of DITPA
1 secondary outcome
Efficacy of DITPA
Results and safety
The study was stopped early (reason given: Study terminated for reasons unrelated to safety or efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 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.
Milton Packer, MD study chair
University of Texas Southwestern Medical Center
22 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 (3,5-diiodothyropropionic acid) in people with Heart Failure, Congestive, run by Titan Pharmaceuticals at 22 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 8 inclusion and 16 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 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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. Some participants in this study may receive a placebo. 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: Study terminated for reasons unrelated to safety or efficacy.). 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.
What does the primary outcome measure?
Safety and tolerability of DITPA. It is what the study was designed to measure, not a finding.
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 29 Mar 2013.