Clinical trial NCT00662116: Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diastolic Heart Failure
Keywords: diastolic heart failure
Lead sponsor: Synvista Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The primary efficacy measure will be exercise tolerance as assessed utilizing the 6 Minute Walk Test
timeFrame: Assessed at baseline, week 12 and week 24
Secondary outcomes:
measure: QOL as assessed by the Kansas City Cardiomyopathy Questionnaire
timeFrame: baseline, week 12 and week 24
measure: To assess New York Heart Association Classification
timeFrame: Baseline, week 12 and week 24
measure: To evaluate cardiovascular death or hospitalization for heart failure
timeFrame: Will be assessed during the entire 24 wk trial
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Anaheim
country: United States
state: California
city: Bakersfield
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Roseville
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Covington
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Auburn
country: United States
state: Maine
city: South Portland
country: United States
state: Maine
city: Ayer
country: United States
state: Massachusetts
city: Lincoln
country: United States
state: Nebraska
city: Ridgewood
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Stonybrook
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Fairfield
country: United States
state: Ohio
city: Sandusky
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Charleston
country: United States
state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: Lackland Airforce Base
country: United States
state: Texas
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: University of Michigan
name: Bertram Pitt, MD
role: PRINCIPAL_INVESTIGATOR
References: