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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00744341
• Date of registration: 28/08/2008
• Prospective Registration: Yes
• Primary sponsor: Solvay Pharmaceuticals
• Public title: Safety and Efficacy Study to Evaluate the Effect of SLV320 on Renal Function in Patients With Worsening Heart Failure
• Scientific title: A Double-Blind, Placebo-Controlled, Randomized, Multi-Center, Dose-Finding Study of SLV320, a Selective A1 Adenosine Receptor Antagonist, to Evaluate the Effect on Renal Function and Safety in Subjects Hospitalized With Acute Decompensated Heart Failure and Renal Dysfunction (Reno-Defend 1)
• Date of first enrolment: February 2009
• Target sample size: 46
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00744341
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Canada, Chile, Denmark, France, Germany, Italy, Poland, Romania, Russian Federation, Ukraine, United States

Contacts

• Name: Robyn Bethany
• Affiliation: Solvay Pharmaceuticals

Key inclusion & 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Decompensated Heart Failure; Renal Dysfunction

Intervention(s)

Drug: Placebo

Drug: SLV320

Primary Outcome(s)

Change in serum creatinine from baseline to Day 14 [Time Frame: Day 14]

Secondary Outcome(s)

To compare four SLV320 doses to placebo on the change in the following variables: Dyspnea (Likert Scale and PDA scale), eGFR (MDRD Formula), Subject Global Clinical Assessment Score, Urine Osmolality, Serum Osmolality [Time Frame: Up to Day 3 (Dyspnea); Up to Day 4 (Urine Osmolality); Up to Day 60 (eGFR, Subject Global Clinical Assessment Score, Serum Osmolality)]

To determine the pharmacokinetic profile of I.V. SLV320 [Time Frame: Up to Day 3]

To compare the effect of four I.V. doses of SLV320 with placebo on top of diuretic use [Time Frame: Up to Day 3]

To compare the effect of four I.V. doses of SLV320 with placebo using a composite endpoint of all-cause mortality, cardiovascular hospitalization or hospitalization for worsening renal function, in time to event and frequency [Time Frame: Up to Day 180]

To compare the effect of four I.V. doses of SLV320 with placebo using the trichotomous endpoint of treatment success, treatment failure, or no change [Time Frame: Up to Day 14]

Secondary ID(s)

S320.2.011

2008-003786-20

00744341

Source(s) of Monetary Support

Please refer to primary and secondary sponsors