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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	August 21, 2008
Last Updated Date	January 29, 2009
Start Date ^†	August 2008
Current Primary Outcome Measures ^† (submitted: August 21, 2008)	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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00739687 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	Safety & Efficacy of ALT-711 (Alagebrium) in Chronic Heart Failure
Official Title ^†	A Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure
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.
Detailed Description
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^†	Chronic Heart Failure
Intervention ^†	Drug: ALT-711 Drug: Placebo
Study Arms / Comparison Groups	Experimental: Alagebrium 200 mg BID Experimental: Placebo
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Terminated
Enrollment ^†	100
Estimated Completion Date	October 2009
Estimated Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00739687
Responsible Party	Adriaan A. Voors, MD, PhD, University Medical Center Groningen, Groningen, The Netherlands
Secondary IDs ^††
Study Sponsor ^†	Synvista Therapeutics, Inc
Collaborators ^††
Investigators ^†
Information Provided By	Synvista Therapeutics, Inc
Verification Date	January 2009
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.