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

This study has been terminated.

(This study was stopped 29OCT2009 due to strategic drug development considerations)

Sponsor:

Information provided by:

Solvay Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00744341

First received: August 28, 2008

Last updated: September 16, 2010

Last verified: September 2010

History of Changes

Purpose

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

Condition	Intervention	Phase
Acute Decompensated Heart Failure; Renal Dysfunction	Drug: SLV320 Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Change in serum creatinine from baseline to Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
To compare the effect of four I.V. doses of SLV320 with placebo on top of diuretic use [ Time Frame: Up to Day 3 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
To determine the pharmacokinetic profile of I.V. SLV320 [ Time Frame: Up to Day 3 ] [ Designated as safety issue: No ]

Enrollment:	46
Study Start Date:	February 2009
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: SLV320 1.25mg i.v. bid
Experimental: 2	Drug: SLV320 3.75mg i.v. bid
Experimental: 3	Drug: SLV320 7.5mg i.v. bid
Experimental: 4	Drug: SLV320 15.0mg i.v. bid
Placebo Comparator: 5	Drug: Placebo

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744341

Show 105 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Robyn Bethany

Solvay Pharmaceuticals

More Information

No publications provided by Solvay Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pang PS, Mehra M, Maggioni AP, Filippatos G, Middlebrooks J, Turlapaty P, Kazei D, Gheorghiade M; RENO-DEFEND Investigators. Rationale, design, and results from RENO-DEFEND 1: A randomized, dose-finding study of the selective A1 adenosine antagonist SLV320 in patients hospitalized with acute heart failure. Am Heart J. 2011 Jun;161(6):1012-23.e3.

ClinicalTrials.gov Identifier:	NCT00744341 History of Changes
Other Study ID Numbers:	S320.2.011, 2008-003786-20, 00744341
Study First Received:	August 28, 2008
Last Updated:	September 16, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:

SLV320; Acute Decompensated Heart Failure (ADHF); chronic heart failure; renal failure; I.V. doses; hospitalization

Additional relevant MeSH terms:

Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Purinergic P1 Receptor Antagonists

Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013

To Top