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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00739687
Other study ID # ALT-711-0527a
Secondary ID
Status Terminated
Phase Phase 2
First received August 21, 2008
Last updated January 29, 2009
Start date August 2008
Est. completion date October 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

Several lines of evidence have suggested that Advanced Glycation End-products (AGEs) play a role in the development and progression of heart failure. The AGE-crosslink breaker Alagebrium improved cardiac function and symptoms in experimental preclinical and small human heart failure studies. These results have not yet been confirmed in a randomized controlled clinical trial. Objective: to evaluate the safety and efficacy of alagebrium in subjects diagnosed with heart failure. This is a randomized, double-blind, placebo-controlled trial to assess the effects of 400 mg (2 x 100 mg bid) of alagebrium versus placebo over 9 months. 100 subjects will be studied (50 per treatment group) in approximately 6 centers. Procedures: exercise testing (VO2 max; the primary variable), ECGs and blood sampling.


Recruitment information / eligibility

Status Terminated
Enrollment 100
Est. completion date October 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- NYHA II-IV heart failure

- Echocardiographic ejection fraction = 45% (echo does not need to be repeated at the screening visit if a prior echo is on record which indicates an ejection fraction < 40%)

- Duration of heart failure > 3 months

- Stable heart failure medical therapy for > 1 month

- Patients need to be able to understand content of and willing to provide informed consent

Exclusion Criteria:

- Patient = 18 years

- History of myocardial infarction in previous 6 months

- History of stroke/TIA/RIND in previous 6 months

- Severe valvular dysfunction

- Severe pulmonary disease

- History of systemic inflammatory or collagen vascular disease

- Active and or treated malignancies within 12 months prior to inclusion

- Any significant condition either medical or non-medical that could lead to difficulty complying with the protocol

- Patients on cardiac resynchronisation therapy (CRT) or scheduled for CRT implantation

- Pacemaker therapy (unless rescue pacing at = 40 bpm) or scheduled pacemaker implantation

- History of valve replacement or surgery

- Uncontrolled diabetes mellitus (HbA1c > 9.5%)

- Clinically significant renal disturbance (sMDRD calculated GFR=30 mL/min/1.73m2; sMDRD is calculated as 186 x serum Cr (mg/dl)-1.154 x years-0.203 x (0.742 if female) x (1.210 if African American)

- Clinically significant liver disease (ASAT/ALAT > 2,5 times the upper limit of normal)

- Severe anemia at baseline (Hemoglobin <10 g/dl or <6.2 mmol/l)

- Use of any investigational drug(s) within 30 days prior to screening

- Pregnancy or active breast-feeding (urine pregnancy tests will be performed on all female subjects of childbearing potential)*

- Active pericarditis/myocarditis

- The inability of patients to undergo exercise testing

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
ALT-711
200 mg tablet BID for 9 months.
Placebo
200 mg tablet BID for 9 months.

Locations

Country Name City State
United States University of Alabama Hospital Birmingham Alabama
United States Medical University of South Carolina (MUSC) Charleston South Carolina
United States Henry Ford Hospital Detroit Michigan
United States Wake Forest University Health Sciences Winston-Salem North Carolina

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 end-point of the study will be aerobic capacity (VO2 max) measured at exercise testing. An improvement of 15% in VO2 max will be considered as a clinically significant increase. 9 months No
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