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

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Effects of Alagebrium on Exercise in Subjects With Diastolic Heart Failure

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00662116

Acronym

BREAK-DHF-I

Enrollment

160

Registered

2008-04-21

Start date

2008-03-31

Completion date

2009-12-31

Last updated

2009-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastolic Heart Failure

Keywords

diastolic heart failure

Brief summary

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.

Interventions

DRUGalagebrium

200 mg (two 100 mg tablets) two times daily for 24 weeks

DRUGplacebo

placebo tablets - two tablets taken twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The primary efficacy measure will be exercise tolerance as assessed utilizing the 6 Minute Walk Test	Assessed at baseline, week 12 and week 24

Secondary

Measure	Time frame
QOL as assessed by the Kansas City Cardiomyopathy Questionnaire	baseline, week 12 and week 24
To assess New York Heart Association Classification	Baseline, week 12 and week 24
To evaluate cardiovascular death or hospitalization for heart failure	Will be assessed during the entire 24 wk trial

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026