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

• Conditions: Heart Failure; MedDRA version: 9.1Level: LLTClassification code 10008908Term: Chronic heart failure

• Registration Number: EUCTR2007-000319-27-NL
• Lead Sponsor: Alteon, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•NYHA II-IV heart failure
•Echocardiographic ejection fraction = 40%
•Duration of heart failure > 3 months
•Stable heart failure medical therapy for > 1 months
•Patients need to be able to understand content of and willing to provide informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
•atrial fibrillation (unless paroxysmal)
•Uncontrolled diabetes mellitus (HbA1c>9.5%)
•Clinically significant renal disturbance (sMDRD calculated GFR=30 mL/min/1,73m^2)
•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 (pregnancy test’s will be performed on all female subjects of childbearing potential)*
•Active pericarditis/myocarditis
•The inability of patients to undergo exercise testing

* All female subjects of childbearing potential (not postmenopausal for at least 1 year or surgically sterilized) must agree not to become pregnant during the duration of the study. Specifically, they must agree to use an appropriate contraceptive regimen. Acceptable regimens include systemic hormones, intrauterine devices and barrier methods (such as cervical caps, male or female condoms, or diaphragms) with concomitant intravaginal spermicide.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified