Diastolic Heart FailurePhase 2BREAK-DHF-INCT00662116
Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (BREAK-DHF-I)
A Phase 2 study testing alagebrium in people with Diastolic Heart Failure, run by Synvista Therapeutics, Inc at 30 sites in United States.
Trial summary
This study is being done to evaluate the safety and effectiveness of alagebrium in subjects diagnosed with diastolic heart failure. The primary assessment for effectiveness is the assessment of exercise tolerance. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diastolic Heart Failure
- What is being tested?
- alagebrium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 30 sitesUnited States
- Study dates
- Mar 2008to Dec 2009
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of diabetes or hypertension requiring therapy
- EF >/= 45% via echo within 1 year and evidence of diastolic heart failure via echo measurement of E/E'>/= 12 determined by echo within 1 year
- previous hospitalization for heart failure or previous BNP >100 pg/mL.
Who cannot join
- Clinically significant valvular disease
- history of stroke/TIA or reversible ischemic neurological defect w/i 6 mths
- history of acute MI within 6 months
- severe COPD
- active or treated malignancies (except basal cell carcinoma)
- significant systemic illnesses that would prohibit completion of the study or compliance
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Study site
Albany, New York, 12205
Study site
Anaheim, California
Study site
Auburn, Maine, 04210
Study site
Ayer, Massachusetts, 01432
Study site
Bakersfield, California, 93308
Study site
Birmingham, Alabama, 35294
Study site
Charleston, South Carolina, 29401
Study site
Cincinnati, Ohio, 45219
Study site
Covington, Georgia, 30014
Study site
Dayton, Ohio, 45414
Study site
Fairfield, Ohio, 45014
Study site
Germantown, Tennessee, 38138
Study site
Huntsville, Alabama, 35801
Study site
Indianapolis, Indiana, 46260
Study site
Jacksonville, Florida, 32209
Study site
La Jolla, California, 92037
Study site
Lackland Airforce Base, Texas
Study site
Lincoln, Nebraska, 68506
Study site
Louisville, Kentucky, 40207
Study site
Miami, Florida, 33136
Study site
Milwaukee, Wisconsin, 53215
Study site
Mobile, Alabama, 36608
Study site
Oklahoma City, Oklahoma, 73112
Study site
Ridgewood, New Jersey, 07450
Study site
Roseville, California, 95661
Study site
Sandusky, Ohio, 44870
Study site
South Portland, Maine, 04106
Study site
St. Petersburg, Florida, 33709
Study site
Stony Brook, New York, 11794
Study site
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Effects of Alagebrium on Exercise in Subjects With Diastolic Heart Failure
This study is being done to evaluate the safety and effectiveness of alagebrium in subjects diagnosed with diastolic heart failure. The primary assessment for effectiveness is the assessment of exercise tolerance.
- Conditions
- Diastolic Heart Failure
- Being tested
- alagebrium, placebo
- Keywords
- diastolic heart failure
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alagebriumDrug
Also called ALT-711
200 mg (two 100 mg tablets) two times daily for 24 weeks
placeboDrug
placebo tablets - two tablets taken twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: alagebrium |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy measure will be exercise tolerance as assessed utilizing the 6 Minute Walk Test
Measured: Assessed at baseline, week 12 and week 24
Secondary outcomes (3)
QOL as assessed by the Kansas City Cardiomyopathy Questionnaire
Measured: baseline, week 12 and week 24
To assess New York Heart Association Classification
Measured: Baseline, week 12 and week 24
To evaluate cardiovascular death or hospitalization for heart failure
Measured: Will be assessed during the entire 24 wk trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: Study has been terminated early due to financial constraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Synvista Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bertram Pitt, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662116
- Sponsor's protocol ID
- ALT-711-0530
- Acronym
- BREAK-DHF-I
- Status last verified
- Jan 2009
- First submitted
- 17 Apr 2008
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Effects of Alagebrium on Exercise in Subjects With Diastolic Heart Failure
- ClinicalTrials.gov ID
- NCT00662116
- Acronym / sponsor ID
- BREAK-DHF-I / ALT-711-0530
- Conditions
- Diastolic Heart Failure
- Keywords
- diastolic heart failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been terminated early due to financial constraints.
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Synvista Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 21 Apr 2008 (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 is being done to evaluate the safety and effectiveness of alagebrium in subjects diagnosed with diastolic heart failure. The primary assessment for effectiveness is the assessment of exercise tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: alagebrium |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of diabetes or hypertension requiring therapy
- EF >/= 45% via echo within 1 year and evidence of diastolic heart failure via echo measurement of E/E'>/= 12 determined by echo within 1 year
- previous hospitalization for heart failure or previous BNP >100 pg/mL.
Key exclusion criteria (6 listed)
- Clinically significant valvular disease
- history of stroke/TIA or reversible ischemic neurological defect w/i 6 mths
- history of acute MI within 6 months
- severe COPD
- active or treated malignancies (except basal cell carcinoma)
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 |
|---|---|---|
| alagebriumAlso: ALT-711200 mg (two 100 mg tablets) two times daily for 24 weeks | Drug | 1 |
| placeboplacebo tablets - two tablets taken twice daily | Drug | 2 |
Primary outcome
The primary efficacy measure will be exercise tolerance as assessed utilizing the 6 Minute Walk Test
Time frame: Assessed at baseline, week 12 and week 24
3 secondary outcomes
QOL as assessed by the Kansas City Cardiomyopathy Questionnaire
Time frame: baseline, week 12 and week 24
To assess New York Heart Association Classification
Time frame: Baseline, week 12 and week 24
To evaluate cardiovascular death or hospitalization for heart failure
Time frame: Will be assessed during the entire 24 wk trial
Results and safety
The study was stopped early (reason given: Study has been terminated early due to financial constraints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
Related trials for Diastolic Heart Failure
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
RecruitingPhase 1
A Study of LY3971297 in Participants With Heart Failure
Heart Failure, Heart Failure, Diastolic
Not yet recruiting
Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
Valvular Heart Disease Patients, Aortic Stenosis
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Recruiting
Assessment of CCM in HF With Higher Ejection Fraction
Heart Failure, Heart Failure With Preserved Ejection Fraction
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.
Bertram Pitt, MD principal investigator
University of Michigan
30 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 alagebrium in people with Diastolic Heart Failure, run by Synvista Therapeutics, Inc at 30 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 3 inclusion and 6 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 30 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 has been terminated early due to financial constraints.). 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?
The primary efficacy measure will be exercise tolerance as assessed utilizing the 6 Minute Walk Test (time frame: Assessed at baseline, week 12 and week 24). 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 30 Jan 2009.