The BENEFICIAL Study: Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure (BENEFICIAL)

January 12, 2010 updated by: Synvista Therapeutics, Inc

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 (ALT-711) improved cardiac function and symptoms in experimental and small human heart failure studies. These results have not yet been confirmed in a randomized controlled clinical trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a double-blind, randomized, placebo-controlled, parallel design trial enrolling 100 patients (2x50) with stable CHF. Patients will be randomized to either 200 mg Alagebrium twice daily or placebo for a period of 9 months. Efficacy measurements will be performed at baseline, and at the end of the study, and include aerobic capacity (VO2max) exercise testing, echocardiography, Minnesota Living with Heart Failure score, AGEs measurements in blood and skin, NYHA heart failure class, patient's and physician's global assessment, and levels of NT-pro-BNP. Safety visits are performed at 3 months intervals. In addition, one safety visit will be performed 2 weeks after the randomization visit and 1 month after the last treatment visit. A total of 8 visits will be performed during the entire study.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • P.O. Box 30 001
      • Groningen, P.O. Box 30 001, Netherlands, 9700 RB
        • Dept. Cardiology - University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • NYHA II-IV heart failure
  • Echocardiographic ejection fraction ≤ 40%
  • Duration of heart failure > 3 months
  • Stable heart failure medical therapy for > 1 months

Exclusion Criteria:

  • History of myocardial infarction in previous 6 months
  • History of stroke in previous 6 months
  • Clinically significant renal, liver, pulmonary,or hematological disease
  • Active and or treated malignancies within 12 months
  • Uncontrolled diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: Placebo
bid
ACTIVE_COMPARATOR: 1
ALT-711 200 mg bid
Drug: ALT-711
200 mg bid
Other Names:
  • Alagebrium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary end-point of the study will be aerobic capacity (VO2max) measured at exercise testing
Time Frame: At baseline and after 9 months of study drug
At baseline and after 9 months of study drug

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in systolic function, diastolic function, advanced glycation end-products (AGE) measurements, changes in Minnesota Living with Heart Failure score, NYHA heart failure score, patient's and physician's global assessment, and NT-pro-BNP
Time Frame: At baseline and after 9 months of study drug
At baseline and after 9 months of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synvista Therapeutics, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

August 13, 2007

First Submitted That Met QC Criteria

August 13, 2007

First Posted (ESTIMATE)

August 15, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALT-711-0527

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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