Heart Failure MedDRA version: 9.1 Level: LLT Classification code 10008908 Term: Chronic heart failure
Conditions
Interventions
Product Name: Alagebrium chloride
Product Code: ALT-711
Pharmaceutical Form: Tablet
INN or Proposed INN: Alagebrium chloride
CAS Number: 341028-37-3
Current Sponsor code: ALT-711
Other descriptive nam
Sponsors
Alteon, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to establish the efficacy and safety of Alagebrium chloride (ALT-711) in patients with chronic heart failure and an impaired left ventricular ejection fraction (<40%) by measuring the effect on aerobic capacity (VO2-max) at exercise testing.;Secondary Objective: 1. Evaluate the effect of ALT-711 on diastolic function measured by tissue velocity imaging (TVI) with echocardiography 2. Evaluate the effect of ALT-711 on systolic function (eye-balling left ventricular ejection fraction) measured with echocardiography 3. Evaluate the effect of ALT-711 on Advanced glycation end-products (AGEs) in tissue measured with skin-autofluorescence and in blood measured with mass spectrometry analysis 4. Evaluate the effect of ALT-711 on Quality of Life (QoL) measured with the Minnesota Living with Heart Failure score 5. Evaluate the effect of ALT-711 on New York Heart Association (NYHA) heart failure class 6. Evaluate the effect of ALT-711 on Patients's and Physician's global assessment scores 7. Evaluate the effect of ALT-711 on levels of N-terminal pro-brain natriuretric peptide (NT-pro-BNP) ;Primary end point(s): The primary end-point of the study will be aerobic capacity(VO2max) measured at exercise testing. An improvement of 15% of VO2max will be considered as a clinical significant increase. | — |
Countries
Netherlands
Outcome results
None listed