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

September 16, 2010 updated by: Solvay Pharmaceuticals

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)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Montreal, Canada
        • S320.2.011 Site # 601
  • Chile
      • Santiago, Chile
        • S320.2.011 Site # 427
      • Viña del Mar, Chile
        • S320.2.011 Site # 433
      • Viña del Mar, Chile
        • S320.2.011 Site # 434
  • Denmark
      • Aarhus, Denmark
        • S320.2.011 Site # 100
      • Aarhus, Denmark
        • S320.2.011 Site # 102
      • Esbjerg, Denmark
        • S320.2.011 Site # 103
      • Frederiksberg, Denmark
        • S320.2.011 Site # 106
      • Herning, Denmark
        • S320.2.011 Site # 105
      • København, Denmark
        • S320.2.011 Site # 104
  • France
      • Dijon, France
        • S320.2.011 Site # 125
      • Lille, France
        • S320.2.011 Site # 123
      • Paris, France
        • S320.2.011 Site # 121
      • Pessac, France
        • S320.2.011 Site # 124
      • Pontoise, France
        • S320.2.011 Site # 126
      • Toulouse, France
        • S320.2.011 Site # 128
  • Germany
      • Bad Nauheim, Germany
        • S320.2.011 Site # 182
      • Berlin, Germany
        • S320.2.011 Site # 187
      • Frankfurt, Germany
        • S320.2.011 Site # 186
      • Hannover, Germany
        • S320.2.011 Site # 180
      • Limburg, Germany
        • S320.2.011 Site # 185
      • Mannheim, Germany
        • S320.2.011 Site # 190
      • Weiden, Germany
        • S320.2.011 Site # 188
  • Italy
      • Aosta, Italy
        • S320.2.011 Site # 146
      • Cremona, Italy
        • S320.2.011 Site # 145
      • Genova, Italy
        • S320.2.011 Site # 142
      • Milano, Italy
        • S320.2.011 Site # 149
      • Modena, Italy
        • S320.2.011 Site # 140
      • Orbassano, Italy
        • S320.2.011 Site # 143
  • Poland
      • Bialystok, Poland
        • S320.2.011 Site # 250
      • Inowroclaw, Poland
        • S320.2.011 Site # 231
      • Krakow, Poland
        • S320.2.011 Site # 236
      • Lodz, Poland
        • S320.2.011 Site # 249
      • Olawa, Poland
        • S320.2.011 Site # 243
      • Plock, Poland
        • S320.2.011 Site # 251
      • Poznan, Poland
        • S320.2.011 Site # 240
      • Przeworsk, Poland
        • S320.2.011 Site # 247
      • Pulawy, Poland
        • S320.2.011 Site # 242
      • Radom, Poland
        • S320.2.011 Site # 239
      • Ruda Slaska, Poland
        • S320.2.011 Site # 232
      • Starogard Gdanski, Poland
        • S320.2.011 Site # 245
      • Torun, Poland
        • S320.2.011 Site # 234
      • Torun, Poland
        • S320.2.011 Site # 248
      • Tychy, Poland
        • S320.2.011 Site # 238
      • Wroclaw, Poland
        • S320.2.011 Site # 233
  • Romania
      • Baia Mare, Romania
        • S320.2.011 Site # 265
      • Braila, Romania
        • S320.2.011 Site # 262
      • Bucuresti, Romania
        • S320.2.011 Site # 260
      • Bucuresti, Romania
        • S320.2.011 Site # 263
      • Bucuresti, Romania
        • S320.2.011 Site # 267
      • Suceava, Romania
        • S320.2.011 Site # 264
      • Targoviste, Romania
        • S320.2.011 Site # 261
      • Timisoara, Romania
        • S320.2.011 Site # 266
  • Russian Federation
      • Kazan, Russian Federation
        • S320.2.011 Site # 294
      • Krasnodar, Russian Federation
        • S320.2.011 Site # 306
      • Moscow, Russian Federation
        • S320.2.011 Site # 290
      • Moscow, Russian Federation
        • S320.2.011 Site # 297
      • Moscow, Russian Federation
        • S320.2.011 Site # 299
      • Moscow, Russian Federation
        • S320.2.011 Site # 301
      • Moscow, Russian Federation
        • S320.2.011 Site # 303
      • Moscow, Russian Federation
        • S320.2.011 Site # 304
      • Moscow, Russian Federation
        • S320.2.011 Site # 305
      • Saint-Petersburg, Russian Federation
        • S320.2.011 Site # 291
      • Saint-Petersburg, Russian Federation
        • S320.2.011 Site # 292
      • Saint-Petersburg, Russian Federation
        • S320.2.011 Site # 298
      • Saint-Petersburg, Russian Federation
        • S320.2.011 Site # 302
      • St. Petersburg, Russian Federation
        • S320.2.011 Site # 300
      • Voronezh, Russian Federation
        • S320.2.011 Site # 293
      • Yaroslavl, Russian Federation
        • S320.2.011 Site # 295
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • S320.2.011 Site # 335
      • Ivano-Frankivsk, Ukraine
        • S320.2.011 Site # 332
      • Kharkiv, Ukraine
        • S320.2.011 Site # 334
      • Kyiv, Ukraine
        • S320.2.011 Site # 330
      • Kyiv, Ukraine
        • S320.2.011 Site # 338
      • Lugansk, Ukraine
        • S320.2.011 Site # 331
      • Lutsk, Ukraine
        • S320.2.011 Site # 333
      • Odessa, Ukraine
        • S320.2.011 Site # 337
  • United States
    • California
      • Alameda, California, United States
        • S320.2.011 Site # 548
      • Banning, California, United States
        • S320.2.011 Site # 566
      • Inglewood, California, United States
        • S320.2.011 Site # 551
    • Connecticut
      • Bridgeport, Connecticut, United States
        • S320.2.011 Site # 564
    • Florida
      • Hollywood, Florida, United States
        • S320.2.011 Site # 505
      • Jacksonville, Florida, United States
        • S320.2.011 Site # 507
    • Georgia
      • Riverdale, Georgia, United States
        • S320.2.011 Site # 532
    • Illinois
      • Chicago, Illinois, United States
        • S320.2.011 Site # 513
    • Indiana
      • Indianapolis, Indiana, United States
        • S320.2.011 Site # 561
    • Kentucky
      • Owensboro, Kentucky, United States
        • S320.2.011 Site # 526
    • Louisiana
      • Natchitoches, Louisiana, United States
        • S320.2.011 Site # 504
    • Maine
      • Biddeford, Maine, United States
        • S320.2.011 Site # 546
    • Michigan
      • Dearborn, Michigan, United States
        • S320.2.011 Site # 523
      • Detroit, Michigan, United States
        • S320.2.011 Site # 534
      • Detroit, Michigan, United States
        • S320.2.011 Site # 558
    • Missouri
      • St. Louis, Missouri, United States
        • S320.2.011 Site # 508
    • New York
      • Brooklyn, New York, United States
        • S320.2.011 Site # 541
      • New York, New York, United States
        • S320.2.011 Site # 537
    • Ohio
      • Akron, Ohio, United States
        • S320.2.011 Site # 521
      • Toledo, Ohio, United States
        • S320.2.011 Site # 527
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • S320.2.011 Site # 528
    • South Carolina
      • Colombia, South Carolina, United States
        • S320.2.011 Site # 510
    • Tennessee
      • Nashville, Tennessee, United States
        • S320.2.011 Site # 545
      • Tullahoma, Tennessee, United States
        • S320.2.011 Site # 519
    • Texas
      • Houston, Texas, United States
        • S320.2.011 Site # 511
      • San Antonio, Texas, United States
        • S320.2.011 Site # 518
    • Wisconsin
      • Manitowoc, Wisconsin, United States
        • S320.2.011 Site # 556
      • Milwaukee, Wisconsin, United States
        • S320.2.011 Site # 565

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: SLV320
1.25mg i.v. bid
Drug: SLV320
3.75mg i.v. bid
Drug: SLV320
7.5mg i.v. bid
Drug: SLV320
15.0mg i.v. bid
Experimental: 2
Drug: SLV320
1.25mg i.v. bid
Drug: SLV320
3.75mg i.v. bid
Drug: SLV320
7.5mg i.v. bid
Drug: SLV320
15.0mg i.v. bid
Experimental: 3
Drug: SLV320
1.25mg i.v. bid
Drug: SLV320
3.75mg i.v. bid
Drug: SLV320
7.5mg i.v. bid
Drug: SLV320
15.0mg i.v. bid
Experimental: 4
Drug: SLV320
1.25mg i.v. bid
Drug: SLV320
3.75mg i.v. bid
Drug: SLV320
7.5mg i.v. bid
Drug: SLV320
15.0mg i.v. bid
Placebo Comparator: 5
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in serum creatinine from baseline to Day 14
Time Frame: Day 14
Day 14

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Up to Day 3 (Dyspnea); Up to Day 4 (Urine Osmolality); Up to Day 60 (eGFR, Subject Global Clinical Assessment Score, Serum Osmolality)
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
Up to Day 14
To compare the effect of four I.V. doses of SLV320 with placebo on top of diuretic use
Time Frame: Up to Day 3
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
Up to Day 180
To determine the pharmacokinetic profile of I.V. SLV320
Time Frame: Up to Day 3
Up to Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Investigators

  • Study Director: Robyn Bethany, Solvay Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 28, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (Estimate)

August 29, 2008

Study Record Updates

Last Update Posted (Estimate)

September 17, 2010

Last Update Submitted That Met QC Criteria

September 16, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S320.2.011
  • 2008-003786-20 (EudraCT Number)
  • 00744341 (Other Grant/Funding Number: NCT/NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Decompensated Heart Failure; Renal Dysfunction

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe