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

Synvista Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Diastolic Heart Failure

Treatments: Drug: placebo; Drug: alagebrium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00662116

ALT-711-0530

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: alagebrium

2

Placebo Comparator group

Treatment:

Drug: placebo