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

Primary Purpose

Acute Decompensated Heart Failure; Renal Dysfunction

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SLV320
SLV320
SLV320
SLV320
Placebo
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Decompensated Heart Failure; Renal Dysfunction focused on measuring SLV320; Acute Decompensated Heart Failure (ADHF); chronic heart failure; renal failure; I.V. doses; hospitalization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • S320.2.011 Site # 548
  • S320.2.011 Site # 566
  • S320.2.011 Site # 551
  • S320.2.011 Site # 564
  • S320.2.011 Site # 505
  • S320.2.011 Site # 507
  • S320.2.011 Site # 532
  • S320.2.011 Site # 513
  • S320.2.011 Site # 561
  • S320.2.011 Site # 526
  • S320.2.011 Site # 504
  • S320.2.011 Site # 546
  • S320.2.011 Site # 523
  • S320.2.011 Site # 534
  • S320.2.011 Site # 558
  • S320.2.011 Site # 508
  • S320.2.011 Site # 541
  • S320.2.011 Site # 537
  • S320.2.011 Site # 521
  • S320.2.011 Site # 527
  • S320.2.011 Site # 528
  • S320.2.011 Site # 510
  • S320.2.011 Site # 545
  • S320.2.011 Site # 519
  • S320.2.011 Site # 511
  • S320.2.011 Site # 518
  • S320.2.011 Site # 556
  • S320.2.011 Site # 565
  • S320.2.011 Site # 601
  • S320.2.011 Site # 427
  • S320.2.011 Site # 433
  • S320.2.011 Site # 434
  • S320.2.011 Site # 100
  • S320.2.011 Site # 102
  • S320.2.011 Site # 103
  • S320.2.011 Site # 106
  • S320.2.011 Site # 105
  • S320.2.011 Site # 104
  • S320.2.011 Site # 125
  • S320.2.011 Site # 123
  • S320.2.011 Site # 121
  • S320.2.011 Site # 124
  • S320.2.011 Site # 126
  • S320.2.011 Site # 128
  • S320.2.011 Site # 182
  • S320.2.011 Site # 187
  • S320.2.011 Site # 186
  • S320.2.011 Site # 180
  • S320.2.011 Site # 185
  • S320.2.011 Site # 190
  • S320.2.011 Site # 188
  • S320.2.011 Site # 146
  • S320.2.011 Site # 145
  • S320.2.011 Site # 142
  • S320.2.011 Site # 149
  • S320.2.011 Site # 140
  • S320.2.011 Site # 143
  • S320.2.011 Site # 250
  • S320.2.011 Site # 231
  • S320.2.011 Site # 236
  • S320.2.011 Site # 249
  • S320.2.011 Site # 243
  • S320.2.011 Site # 251
  • S320.2.011 Site # 240
  • S320.2.011 Site # 247
  • S320.2.011 Site # 242
  • S320.2.011 Site # 239
  • S320.2.011 Site # 232
  • S320.2.011 Site # 245
  • S320.2.011 Site # 234
  • S320.2.011 Site # 248
  • S320.2.011 Site # 238
  • S320.2.011 Site # 233
  • S320.2.011 Site # 265
  • S320.2.011 Site # 262
  • S320.2.011 Site # 260
  • S320.2.011 Site # 263
  • S320.2.011 Site # 267
  • S320.2.011 Site # 264
  • S320.2.011 Site # 261
  • S320.2.011 Site # 266
  • S320.2.011 Site # 294
  • S320.2.011 Site # 306
  • S320.2.011 Site # 290
  • S320.2.011 Site # 297
  • S320.2.011 Site # 299
  • S320.2.011 Site # 301
  • S320.2.011 Site # 303
  • S320.2.011 Site # 304
  • S320.2.011 Site # 305
  • S320.2.011 Site # 291
  • S320.2.011 Site # 292
  • S320.2.011 Site # 298
  • S320.2.011 Site # 302
  • S320.2.011 Site # 300
  • S320.2.011 Site # 293
  • S320.2.011 Site # 295
  • S320.2.011 Site # 335
  • S320.2.011 Site # 332
  • S320.2.011 Site # 334
  • S320.2.011 Site # 330
  • S320.2.011 Site # 338
  • S320.2.011 Site # 331
  • S320.2.011 Site # 333
  • S320.2.011 Site # 337

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

5

Arm Description

Outcomes

Primary Outcome Measures

Change in serum creatinine from baseline to Day 14

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
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
To compare the effect of four I.V. doses of SLV320 with placebo on top of diuretic use
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
To determine the pharmacokinetic profile of I.V. SLV320

Full Information

First Posted
August 28, 2008
Last Updated
September 16, 2010
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00744341
Brief Title
Safety and Efficacy Study to Evaluate the Effect of SLV320 on Renal Function in Patients With Worsening Heart Failure
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Terminated
Why Stopped
This study was stopped 29OCT2009 due to strategic drug development considerations
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure; Renal Dysfunction
Keywords
SLV320; Acute Decompensated Heart Failure (ADHF); chronic heart failure; renal failure; I.V. doses; hospitalization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SLV320
Intervention Description
1.25mg i.v. bid
Intervention Type
Drug
Intervention Name(s)
SLV320
Intervention Description
3.75mg i.v. bid
Intervention Type
Drug
Intervention Name(s)
SLV320
Intervention Description
7.5mg i.v. bid
Intervention Type
Drug
Intervention Name(s)
SLV320
Intervention Description
15.0mg i.v. bid
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in serum creatinine from baseline to Day 14
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
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)
Title
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
Title
To compare the effect of four I.V. doses of SLV320 with placebo on top of diuretic use
Time Frame
Up to Day 3
Title
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
Title
To determine the pharmacokinetic profile of I.V. SLV320
Time Frame
Up to Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robyn Bethany
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
S320.2.011 Site # 548
City
Alameda
State/Province
California
Country
United States
Facility Name
S320.2.011 Site # 566
City
Banning
State/Province
California
Country
United States
Facility Name
S320.2.011 Site # 551
City
Inglewood
State/Province
California
Country
United States
Facility Name
S320.2.011 Site # 564
City
Bridgeport
State/Province
Connecticut
Country
United States
Facility Name
S320.2.011 Site # 505
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
S320.2.011 Site # 507
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
S320.2.011 Site # 532
City
Riverdale
State/Province
Georgia
Country
United States
Facility Name
S320.2.011 Site # 513
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
S320.2.011 Site # 561
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
S320.2.011 Site # 526
City
Owensboro
State/Province
Kentucky
Country
United States
Facility Name
S320.2.011 Site # 504
City
Natchitoches
State/Province
Louisiana
Country
United States
Facility Name
S320.2.011 Site # 546
City
Biddeford
State/Province
Maine
Country
United States
Facility Name
S320.2.011 Site # 523
City
Dearborn
State/Province
Michigan
Country
United States
Facility Name
S320.2.011 Site # 534
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
S320.2.011 Site # 558
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
S320.2.011 Site # 508
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
S320.2.011 Site # 541
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
S320.2.011 Site # 537
City
New York
State/Province
New York
Country
United States
Facility Name
S320.2.011 Site # 521
City
Akron
State/Province
Ohio
Country
United States
Facility Name
S320.2.011 Site # 527
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
S320.2.011 Site # 528
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
S320.2.011 Site # 510
City
Colombia
State/Province
South Carolina
Country
United States
Facility Name
S320.2.011 Site # 545
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
S320.2.011 Site # 519
City
Tullahoma
State/Province
Tennessee
Country
United States
Facility Name
S320.2.011 Site # 511
City
Houston
State/Province
Texas
Country
United States
Facility Name
S320.2.011 Site # 518
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
S320.2.011 Site # 556
City
Manitowoc
State/Province
Wisconsin
Country
United States
Facility Name
S320.2.011 Site # 565
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
S320.2.011 Site # 601
City
Montreal
Country
Canada
Facility Name
S320.2.011 Site # 427
City
Santiago
Country
Chile
Facility Name
S320.2.011 Site # 433
City
Viña del Mar
Country
Chile
Facility Name
S320.2.011 Site # 434
City
Viña del Mar
Country
Chile
Facility Name
S320.2.011 Site # 100
City
Aarhus
Country
Denmark
Facility Name
S320.2.011 Site # 102
City
Aarhus
Country
Denmark
Facility Name
S320.2.011 Site # 103
City
Esbjerg
Country
Denmark
Facility Name
S320.2.011 Site # 106
City
Frederiksberg
Country
Denmark
Facility Name
S320.2.011 Site # 105
City
Herning
Country
Denmark
Facility Name
S320.2.011 Site # 104
City
København
Country
Denmark
Facility Name
S320.2.011 Site # 125
City
Dijon
Country
France
Facility Name
S320.2.011 Site # 123
City
Lille
Country
France
Facility Name
S320.2.011 Site # 121
City
Paris
Country
France
Facility Name
S320.2.011 Site # 124
City
Pessac
Country
France
Facility Name
S320.2.011 Site # 126
City
Pontoise
Country
France
Facility Name
S320.2.011 Site # 128
City
Toulouse
Country
France
Facility Name
S320.2.011 Site # 182
City
Bad Nauheim
Country
Germany
Facility Name
S320.2.011 Site # 187
City
Berlin
Country
Germany
Facility Name
S320.2.011 Site # 186
City
Frankfurt
Country
Germany
Facility Name
S320.2.011 Site # 180
City
Hannover
Country
Germany
Facility Name
S320.2.011 Site # 185
City
Limburg
Country
Germany
Facility Name
S320.2.011 Site # 190
City
Mannheim
Country
Germany
Facility Name
S320.2.011 Site # 188
City
Weiden
Country
Germany
Facility Name
S320.2.011 Site # 146
City
Aosta
Country
Italy
Facility Name
S320.2.011 Site # 145
City
Cremona
Country
Italy
Facility Name
S320.2.011 Site # 142
City
Genova
Country
Italy
Facility Name
S320.2.011 Site # 149
City
Milano
Country
Italy
Facility Name
S320.2.011 Site # 140
City
Modena
Country
Italy
Facility Name
S320.2.011 Site # 143
City
Orbassano
Country
Italy
Facility Name
S320.2.011 Site # 250
City
Bialystok
Country
Poland
Facility Name
S320.2.011 Site # 231
City
Inowroclaw
Country
Poland
Facility Name
S320.2.011 Site # 236
City
Krakow
Country
Poland
Facility Name
S320.2.011 Site # 249
City
Lodz
Country
Poland
Facility Name
S320.2.011 Site # 243
City
Olawa
Country
Poland
Facility Name
S320.2.011 Site # 251
City
Plock
Country
Poland
Facility Name
S320.2.011 Site # 240
City
Poznan
Country
Poland
Facility Name
S320.2.011 Site # 247
City
Przeworsk
Country
Poland
Facility Name
S320.2.011 Site # 242
City
Pulawy
Country
Poland
Facility Name
S320.2.011 Site # 239
City
Radom
Country
Poland
Facility Name
S320.2.011 Site # 232
City
Ruda Slaska
Country
Poland
Facility Name
S320.2.011 Site # 245
City
Starogard Gdanski
Country
Poland
Facility Name
S320.2.011 Site # 234
City
Torun
Country
Poland
Facility Name
S320.2.011 Site # 248
City
Torun
Country
Poland
Facility Name
S320.2.011 Site # 238
City
Tychy
Country
Poland
Facility Name
S320.2.011 Site # 233
City
Wroclaw
Country
Poland
Facility Name
S320.2.011 Site # 265
City
Baia Mare
Country
Romania
Facility Name
S320.2.011 Site # 262
City
Braila
Country
Romania
Facility Name
S320.2.011 Site # 260
City
Bucuresti
Country
Romania
Facility Name
S320.2.011 Site # 263
City
Bucuresti
Country
Romania
Facility Name
S320.2.011 Site # 267
City
Bucuresti
Country
Romania
Facility Name
S320.2.011 Site # 264
City
Suceava
Country
Romania
Facility Name
S320.2.011 Site # 261
City
Targoviste
Country
Romania
Facility Name
S320.2.011 Site # 266
City
Timisoara
Country
Romania
Facility Name
S320.2.011 Site # 294
City
Kazan
Country
Russian Federation
Facility Name
S320.2.011 Site # 306
City
Krasnodar
Country
Russian Federation
Facility Name
S320.2.011 Site # 290
City
Moscow
Country
Russian Federation
Facility Name
S320.2.011 Site # 297
City
Moscow
Country
Russian Federation
Facility Name
S320.2.011 Site # 299
City
Moscow
Country
Russian Federation
Facility Name
S320.2.011 Site # 301
City
Moscow
Country
Russian Federation
Facility Name
S320.2.011 Site # 303
City
Moscow
Country
Russian Federation
Facility Name
S320.2.011 Site # 304
City
Moscow
Country
Russian Federation
Facility Name
S320.2.011 Site # 305
City
Moscow
Country
Russian Federation
Facility Name
S320.2.011 Site # 291
City
Saint-Petersburg
Country
Russian Federation
Facility Name
S320.2.011 Site # 292
City
Saint-Petersburg
Country
Russian Federation
Facility Name
S320.2.011 Site # 298
City
Saint-Petersburg
Country
Russian Federation
Facility Name
S320.2.011 Site # 302
City
Saint-Petersburg
Country
Russian Federation
Facility Name
S320.2.011 Site # 300
City
St. Petersburg
Country
Russian Federation
Facility Name
S320.2.011 Site # 293
City
Voronezh
Country
Russian Federation
Facility Name
S320.2.011 Site # 295
City
Yaroslavl
Country
Russian Federation
Facility Name
S320.2.011 Site # 335
City
Dnipropetrovsk
Country
Ukraine
Facility Name
S320.2.011 Site # 332
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
S320.2.011 Site # 334
City
Kharkiv
Country
Ukraine
Facility Name
S320.2.011 Site # 330
City
Kyiv
Country
Ukraine
Facility Name
S320.2.011 Site # 338
City
Kyiv
Country
Ukraine
Facility Name
S320.2.011 Site # 331
City
Lugansk
Country
Ukraine
Facility Name
S320.2.011 Site # 333
City
Lutsk
Country
Ukraine
Facility Name
S320.2.011 Site # 337
City
Odessa
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
21641345
Citation
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. doi: 10.1016/j.ahj.2011.03.004.
Results Reference
derived

Learn more about this trial

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

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