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

Diastolic Heart Failure Clinical Trial

— BREAK-DHF-I  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00662116
• Other study ID #: ALT-711-0530
• Status: Terminated
• Phase: Phase 2
• First received: April 17, 2008
• Last updated: January 29, 2009
• Start date: March 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2009
• Source: Synvista Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 160
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diastolic Heart Failure
• Heart Failure
• Heart Failure, Diastolic

Intervention

Drug:
• alagebrium
200 mg (two 100 mg tablets) two times daily for 24 weeks
• placebo
placebo tablets - two tablets taken twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Synvista Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy measure will be exercise tolerance as assessed utilizing the 6 Minute Walk Test		Assessed at baseline, week 12 and week 24	No
Secondary	QOL as assessed by the Kansas City Cardiomyopathy Questionnaire		baseline, week 12 and week 24	No
Secondary	To assess New York Heart Association Classification		Baseline, week 12 and week 24	No
Secondary	To evaluate cardiovascular death or hospitalization for heart failure		Will be assessed during the entire 24 wk trial	Yes