Overview
Safety and Efficacy Study to Evaluate the Effect of SLV320 on Renal Function in Patients With Worsening Heart Failure
Status:
Terminated
Terminated
Trial end date:
2010-01-01
2010-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Solvay Pharmaceuticals
Criteria
Inclusion Criteria Renal dysfunction defined as estimated eGFR of 20-80 mL/min; history ofsystolic or diastolic chronic heart failure of at least 14 days duration for which loop
diuretic therapy has been prescribed; clinical evidence for volume overload; BNP ≥ 500
pg/mL or NT-pro-BNP > 2000 pg/mL; hospitalization.
Exclusion Criteria Have low output syndrome, defined as having the need for treatment with
I.V. inotropes or vasopressors; Need mechanical ventilation; Have significant stenotic
valvular disease (severe aortic or mitral stenosis); Have myocardial infarction or
hemodynamically destabilizing significant arrythmias (ventricular tachycardia,
bradyarrythmias with slow ventricular rate [<45 bpm] or atrial fibrillation/flutter with a
rapid ventricular response of >120 bpm), or electrocardiographic evidence of 2nd degree
heart block (Mobitz Type II) or 3rd degree AV-block in the absence of a pacemaker, within
30 days of screening; Have acute myocarditis or hypertrophic obstructive, restrictive, or
constrictive cardiomyopathy