Status:
TERMINATED
Safety and Efficacy Study to Evaluate the Effect of SLV320 on Renal Function in Patients With Worsening Heart Failure
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Acute Decompensated Heart Failure; Renal Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.
Detailed Description
The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.
Eligibility Criteria
Inclusion
- Inclusion Criteria Renal dysfunction defined as estimated eGFR of 20-80 mL/min; history of systolic 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
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00744341
Start Date
February 1 2009
End Date
January 1 2010
Last Update
September 17 2010
Active Locations (105)
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1
S320.2.011 Site # 548
Alameda, California, United States
2
S320.2.011 Site # 566
Banning, California, United States
3
S320.2.011 Site # 551
Inglewood, California, United States
4
S320.2.011 Site # 564
Bridgeport, Connecticut, United States