Diastolic Heart FailurePhase 2BREAK-DHF-1NCT01913301
A Randomized Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Effects of Alagebrium on Exercise in Subjects With Diastolic Heart Failure
A Phase 2 study testing Alagebrium in people with Diastolic Heart Failure, run by Cardiovascular Clinical Sciences Inc.
Trial summary
The purpose of the study is to gather information regarding the safety and effectiveness of an investigational drug called Alagebrium when used treating Heart Failure in relation to exercise tolerance after 6 months in the trial. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to May 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
- Males and females 50 years of age or older.
- Diagnosis of diabetes OR a diagnosis of hypertension requiring therapy.
- Echocardiographic ejection fraction ≥ 45% verified within 1 year prior to baseline, assuming no intercurrent cardiac event between the echo and screening.
- Echocardiographic evidence of diastolic dysfunction as defined by an E/E' ≥ 12 determined within 1 year prior to baseline; sinus rhythm required at time of echo.
- Previous hospitalization due to heart failure OR a current or previous BNP ≥ 100 pg/mL.
- New York Heart Association (NYHA) functional class II-IV.
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- At least 1 month between hospitalization for heart failure and randomization.
- Stable doses of heart failure medications (diuretics, ACE inhibitors, ARB's, beta-adrenergic antagonists, aldosterone antagonists) for at least 1 month prior to randomization.
- Able to understand content of and willing to provide written informed consent.
- Agree to use adequate contraception during the study if premenopausal. -
Who cannot join
- Ejection fraction < 45%.
- Screening Six-minute walk test > 450 meters or < 100 meters
- Clinically significant cardiac valvular disease (mitral regurgitation (MR) > grade I, aortic insufficiency (AI) > grade 1, mitral stenosis (MS), aortic stenosis (AS)).
- History of stroke, any sequelae of a transient ischemic attack (TIA), or reversible ischemic neurological defect (RIND) within 6 months prior to screening.
- History of acute myocardial infarction within 6 months prior to screening.
- Severe COPD as defined by O2 or steroid dependence.
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- History of systemic inflammatory or collagen vascular disease.
- Active and or treated malignancies within 12 months prior to Visit 1 with the exception of basal cell carcinoma.
- Any significant systemic illness(es) or medical condition(s) that could lead to difficulty complying with the protocol; or any concurrent condition(s) which, in the investigator's opinion, would prohibit the subject from completing the study, or would not be in the best interest of the subject.
- Estimated glomerular filtration rate (GFR) ≤ 30 mL/min/1.73m² as calculated by Modification of Diet in Renal Disease (MDRD) study equation [MDRD = 186 X serum creatinine (mg/dl) 1.154 X years -0.203 X (0.742 if female) X (1.210 if African American)].
- Liver function tests (SGOT and/or SGPT) > 2.5 times the upper limit of normal range.
- Hb < 10 g/dL.
- Use of any investigational drug(s) within 30 days prior to screening.
- Previous exposure to alagebrium.
- Known seropositivity for HIV or hepatitis C, or presence of hepatitis B surface antigen.
- Pregnancy or active breast-feeding. Urine pregnancy tests will be performed on all women who are not post-menopausal for at least 1 year.
- -
About this study
The purpose of the study is to gather information regarding the safety and effectiveness of an investigational drug called Alagebrium when used treating Heart Failure in relation to exercise tolerance after 6 months in the trial.
- Conditions
- Diastolic Heart Failure
- Being tested
- Alagebrium
- 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
| Study group | Role | What they receive |
|---|---|---|
| Alagebrium | Experimental | Not described Receives: Drug: Alagebrium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Tolerance
To evaluate the safety and efficacy of alagebrium in subjects diagnosed with diastolic heart failure. The primary variable for assessing efficacy will be assessment of exercise tolerance using the Six-minute walk test.
Measured: Change from baseline at Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startDec 2007
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: Sponsor lost funding
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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Clinical Sciences Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913301
- Sponsor's protocol ID
- ALT-711-0530
- Acronym
- BREAK-DHF-1
- Status last verified
- Feb 2013
- First submitted
- 15 Feb 2013
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. 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
- NCT01913301
- Acronym / sponsor ID
- BREAK-DHF-1 / ALT-711-0530
- Conditions
- Diastolic Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor lost funding
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Cardiovascular Clinical Sciences IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 1 Aug 2013 (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.
The purpose of the study is to gather information regarding the safety and effectiveness of an investigational drug called Alagebrium when used treating Heart Failure in relation to exercise tolerance after 6 months in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alagebrium | Experimental | Drug: Alagebrium |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females 50 years of age or older.
- Diagnosis of diabetes OR a diagnosis of hypertension requiring therapy.
- Echocardiographic ejection fraction ≥ 45% verified within 1 year prior to baseline, assuming no intercurrent cardiac event between the echo and screening.
- Echocardiographic evidence of diastolic dysfunction as defined by an E/E' ≥ 12 determined within 1 year prior to baseline; sinus rhythm required at time of echo.
- Previous hospitalization due to heart failure OR a current or previous BNP ≥ 100 pg/mL.
Key exclusion criteria (17 listed)
- Ejection fraction < 45%.
- Screening Six-minute walk test > 450 meters or < 100 meters
- Clinically significant cardiac valvular disease (mitral regurgitation (MR) > grade I, aortic insufficiency (AI) > grade 1, mitral stenosis (MS), aortic stenosis (AS)).
- History of stroke, any sequelae of a transient ischemic attack (TIA), or reversible ischemic neurological defect (RIND) within 6 months prior to screening.
- History of acute myocardial infarction within 6 months prior to screening.
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 |
|---|---|---|
| Alagebrium | Drug | Alagebrium |
Primary outcome
Exercise Tolerance
Time frame: Change from baseline at Week 24
To evaluate the safety and efficacy of alagebrium in subjects diagnosed with diastolic heart failure. The primary variable for assessing efficacy will be assessment of exercise tolerance using the Six-minute walk test.
Results and safety
The study was stopped early (reason given: Sponsor lost funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alagebrium in people with Diastolic Heart Failure, run by Cardiovascular Clinical Sciences Inc.
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 10 inclusion and 17 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 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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: Sponsor lost funding). 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?
Exercise Tolerance (time frame: Change from baseline at 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 1 Aug 2013.