Safety & Efficacy of ALT-711 (Alagebrium) in Chronic Heart Failure

NCT00739687 | Terminated Phase 2

• 1 other identifier: ALT-711-0527a
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Chronic Heart Failure

Keywords

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ALT-711

EXPERIMENTAL

Alagebrium 200 mg BID

Drug: ALT-711

Placebo

EXPERIMENTAL

Placebo

Drug: Placebo

Interventions

ALT-711 DRUG

200 mg tablet BID for 9 months.

Also known as: Alagebrium

ALT-711

Placebo DRUG

200 mg tablet BID for 9 months.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Synvista Therapeutics, Inc: lead

Study Sites (4)

University of Alabama Hospital

Birmingham, Alabama, 35294, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29403, United States

Location

MeSH Terms

Interventions

alagebrium

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 21, 2008
• First Posted: August 22, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 30, 2009

Record last verified: 2009-01

Locations

US (4)