Safety and Efficacy Study to Evaluate the Effect of SLV320 on Renal Function in Patients With Worsening Heart Failure

Solvay

Status and phase: Terminated; Phase 2

Conditions: Acute Decompensated Heart Failure; Renal Dysfunction

Treatments: Drug: Placebo; Drug: SLV320

Study type: Interventional

Funder types: Industry

Identifiers

NCT00744341

S320.2.011

00744341 (Other Grant/Funding Number)

2008-003786-20 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.

Full description

The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 5 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: SLV320

Drug: SLV320

Drug: SLV320

Drug: SLV320

2

Experimental group

Treatment:

Drug: SLV320

Drug: SLV320

Drug: SLV320

Drug: SLV320

3

Experimental group

Treatment:

Drug: SLV320

Drug: SLV320

Drug: SLV320

Drug: SLV320

4

Experimental group

Treatment:

Drug: SLV320

Drug: SLV320

Drug: SLV320

Drug: SLV320

5

Placebo Comparator group

Treatment:

Drug: Placebo