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

Primary Purpose

Chronic Heart Failure

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ALT-711

Placebo

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Alabama Hospital
Henry Ford Hospital
Wake Forest University Health Sciences
Medical University of South Carolina (MUSC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ALT-711

Placebo

Arm Description

Alagebrium 200 mg BID

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00739687

First Posted

August 21, 2008

Last Updated

January 29, 2009

Sponsor

Synvista Therapeutics, Inc

1. Study Identification

Unique Protocol Identification Number

NCT00739687

Brief Title

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

Acronym

BENEFICIAL

Official Title

A Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Terminated

Why Stopped

Study has been termination early due to financial constraints.

Study Start Date

August 2008 (undefined)

Primary Completion Date

August 2009 (Anticipated)

Study Completion Date

October 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Synvista Therapeutics, Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure

Keywords

Chronic Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ALT-711

Arm Type

Experimental

Arm Description

Alagebrium 200 mg BID

Arm Title

Placebo

Arm Type

Experimental

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

ALT-711

Other Intervention Name(s)

Alagebrium

Intervention Description

200 mg tablet BID for 9 months.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

200 mg tablet BID for 9 months.

Primary Outcome Measure Information:

Title

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.

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University of Alabama Hospital

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Medical University of South Carolina (MUSC)

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29403

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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