Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (BREAK-DHF-I)

This study has been terminated.

( Study has been terminated early due to financial constraints. )

First Received: April 17, 2008 Last Updated: January 29, 2009 History of Changes

Sponsored by:	Synvista Therapeutics, Inc
Information provided by:	Synvista Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT00662116

Purpose

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.

Condition	Intervention	Phase
Diastolic Heart Failure	Drug: alagebrium Drug: placebo	Phase II

MedlinePlus related topics: Exercise and Physical Fitness Heart Failure

Drug Information available for: Alagebrium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Synvista Therapeutics, Inc:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

QOL as assessed by the Kansas City Cardiomyopathy Questionnaire [ Time Frame: baseline, week 12 and week 24 ] [ Designated as safety issue: No ]
To assess New York Heart Association Classification [ Time Frame: Baseline, week 12 and week 24 ] [ Designated as safety issue: No ]
To evaluate cardiovascular death or hospitalization for heart failure [ Time Frame: Will be assessed during the entire 24 wk trial ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	160
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: alagebrium 200 mg (two 100 mg tablets) two times daily for 24 weeks
2: Placebo Comparator	Drug: placebo placebo tablets - two tablets taken twice daily

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662116

Show 30 Study Locations

Sponsors and Collaborators

Synvista Therapeutics, Inc

Investigators

Principal Investigator:

Bertram Pitt, MD

University of Michigan

More Information

No publications provided

Responsible Party:	Synvista ( Carl Mendel, MD/Chief Medical Officer )
Study ID Numbers:	ALT-711-0530
Study First Received:	April 17, 2008
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00662116 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Synvista Therapeutics, Inc:

diastolic heart failure

Study placed in the following topic categories:

Heart Failure, Diastolic
Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure, Diastolic
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009