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Chronic Heart FailurePhase 2BENEFICIALNCT00739687

Safety & Efficacy of ALT-711 (Alagebrium) in Chronic Heart Failure

A Phase 2 study testing ALT-711 in people with Chronic Heart Failure, run by Synvista Therapeutics, Inc at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Several lines of evidence have suggested that Advanced Glycation End-products (AGEs) play a role in the development and progression of heart failure. The AGE-crosslink breaker Alagebrium improved cardiac function and symptoms in experimental preclinical and small human heart failure studies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure
What is being tested?
ALT-711
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
4 sitesUnited States
Study dates
Aug 2008to Oct 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • NYHA II-IV heart failure
  • Echocardiographic ejection fraction ≤ 45% (echo does not need to be repeated at the screening visit if a prior echo is on record which indicates an ejection fraction < 40%)
  • Duration of heart failure > 3 months
  • Stable heart failure medical therapy for > 1 month
  • Patients need to be able to understand content of and willing to provide informed consent

Who cannot join

  • Patient ≤ 18 years
  • History of myocardial infarction in previous 6 months
  • History of stroke/TIA/RIND in previous 6 months
  • Severe valvular dysfunction
  • Severe pulmonary disease
  • History of systemic inflammatory or collagen vascular disease
Show all 19Show fewer
  • Active and or treated malignancies within 12 months prior to inclusion
  • Any significant condition either medical or non-medical that could lead to difficulty complying with the protocol
  • Patients on cardiac resynchronisation therapy (CRT) or scheduled for CRT implantation
  • Pacemaker therapy (unless rescue pacing at ≤ 40 bpm) or scheduled pacemaker implantation
  • History of valve replacement or surgery
  • Uncontrolled diabetes mellitus (HbA1c > 9.5%)
  • Clinically significant renal disturbance (sMDRD calculated GFR≤30 mL/min/1.73m2; sMDRD is calculated as 186 x serum Cr (mg/dl)-1.154 x years-0.203 x (0.742 if female) x (1.210 if African American)
  • Clinically significant liver disease (ASAT/ALAT > 2,5 times the upper limit of normal)
  • Severe anemia at baseline (Hemoglobin <10 g/dl or <6.2 mmol/l)
  • Use of any investigational drug(s) within 30 days prior to screening
  • Pregnancy or active breast-feeding (urine pregnancy tests will be performed on all female subjects of childbearing potential)*
  • Active pericarditis/myocarditis
  • The inability of patients to undergo exercise testing

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Alabama Hospital

    Birmingham, Alabama, 35294

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29403

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure

Several lines of evidence have suggested that Advanced Glycation End-products (AGEs) play a role in the development and progression of heart failure. The AGE-crosslink breaker Alagebrium improved cardiac function and symptoms in experimental preclinical and small human heart failure studies. These results have not yet been confirmed in a randomized controlled clinical trial. Objective: to evaluate the safety and efficacy of alagebrium in subjects diagnosed with heart failure. This is a randomized, double-blind, placebo-controlled trial to assess the effects of 400 mg (2 x 100 mg bid) of alagebrium versus placebo over 9 months. 100 subjects will be studied (50 per treatment group) in approximately 6 centers. Procedures: exercise testing (VO2 max; the primary variable), ECGs and blood sampling.

Being tested
ALT-711, Placebo
Keywords
Chronic Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALT-711Drug

    Also called Alagebrium

    200 mg tablet BID for 9 months.

  • PlaceboDrug

    200 mg tablet BID for 9 months.

Study groups in NCT00739687
Study groupRoleWhat they receive
ALT-711ExperimentalAlagebrium 200 mg BID
Receives: Drug: ALT-711
PlaceboExperimentalPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary end-point of the study will be aerobic capacity (VO2 max) measured at exercise testing. An improvement of 15% in VO2 max will be considered as a clinically significant increase.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionAug 2009 (estimated)
  4. Study completionOct 2009 (estimated)

Why it stopped: Study has been termination early due to financial constraints.

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00739687
Sponsor's protocol ID
ALT-711-0527a
Acronym
BENEFICIAL
Status last verified
Jan 2009
First submitted
21 Aug 2008
Last updated
30 Jan 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALT-711 in people with Chronic Heart Failure, run by Synvista Therapeutics, Inc at 4 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 5 inclusion and 19 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 4 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: Study has been termination 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 end-point of the study will be aerobic capacity (VO2 max) measured at exercise testing. An improvement of 15% in VO2 max will be considered as a clinically significant increase. (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00739687.

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.

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