NCT00516646

Brief 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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2 heart-failure

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

January 13, 2010

Status Verified

April 1, 2009

Enrollment Period

2 years

First QC Date

August 13, 2007

Last Update Submit

January 12, 2010

Conditions

Heart Failure

Keywords

Advanced Glycation End-products (AGEs)Alegebrium

Outcome Measures

Primary Outcomes (1)

  • The primary end-point of the study will be aerobic capacity (VO2max) measured at exercise testing

    At baseline and after 9 months of study drug

Secondary Outcomes (1)

  • 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

    At baseline and after 9 months of study drug

Study Arms (2)

1

ACTIVE COMPARATOR

ALT-711 200 mg bid

Drug: ALT-711

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ALT-711DRUG

200 mg bid

Also known as: Alagebrium
1
PlaceboDRUG

bid

2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Cardiology - University Medical Center Groningen

Groningen, P.O. Box 30 001, 9700 RB, Netherlands

Location

Related Publications (4)

  • Thohan V, Koerner MM, Pratt CM, Torre GA. Improvements in Diastolic Function Among Patients with Advanced Systolic Heart Failure Utilizing Alagebrium (an Oral Advanced Glycation End-product Cross-link Breaker). American Heart Association Scientific Sessions . 2005. Ref Type: Abstract

    BACKGROUND

  • Little WC, Zile MR, Kitzman DW, Hundley WG, O'Brien TX, Degroof RC. The effect of alagebrium chloride (ALT-711), a novel glucose cross-link breaker, in the treatment of elderly patients with diastolic heart failure. J Card Fail. 2005 Apr;11(3):191-5. doi: 10.1016/j.cardfail.2004.09.010.

    PMID: 15812746BACKGROUND

  • Hartog JW, Willemsen S, van Veldhuisen DJ, Posma JL, van Wijk LM, Hummel YM, Hillege HL, Voors AA; BENEFICIAL investigators. Effects of alagebrium, an advanced glycation endproduct breaker, on exercise tolerance and cardiac function in patients with chronic heart failure. Eur J Heart Fail. 2011 Aug;13(8):899-908. doi: 10.1093/eurjhf/hfr067. Epub 2011 Jun 13.

    PMID: 21669961DERIVED

  • Willemsen S, Hartog JW, Hummel YM, Posma JL, van Wijk LM, van Veldhuisen DJ, Voors AA. Effects of alagebrium, an advanced glycation end-product breaker, in patients with chronic heart failure: study design and baseline characteristics of the BENEFICIAL trial. Eur J Heart Fail. 2010 Mar;12(3):294-300. doi: 10.1093/eurjhf/hfp207. Epub 2010 Jan 25.

    PMID: 20100811DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

alagebrium

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Adriaan A Voors, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 15, 2007

Study Start

August 1, 2007

Primary Completion

August 1, 2009

Study Completion

October 1, 2009

Last Updated

January 13, 2010

Record last verified: 2009-04

Locations

NL(1)