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

NCT ID: NCT00744341

Last Updated: 2010-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-01-31

Brief Summary

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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

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

Conditions

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Acute Decompensated Heart Failure; Renal Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

SLV320

Intervention Type DRUG

1.25mg i.v. bid

2

Group Type EXPERIMENTAL

SLV320

Intervention Type DRUG

3.75mg i.v. bid

3

Group Type EXPERIMENTAL

SLV320

Intervention Type DRUG

7.5mg i.v. bid

4

Group Type EXPERIMENTAL

SLV320

Intervention Type DRUG

15.0mg i.v. bid

5

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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SLV320

1.25mg i.v. bid

Intervention Type DRUG

SLV320

3.75mg i.v. bid

Intervention Type DRUG

SLV320

7.5mg i.v. bid

Intervention Type DRUG

SLV320

15.0mg i.v. bid

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Robyn Bethany

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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S320.2.011 Site # 548

Alameda, California, United States

Site Status

S320.2.011 Site # 566

Banning, California, United States

Site Status

S320.2.011 Site # 551

Inglewood, California, United States

Site Status

S320.2.011 Site # 564

Bridgeport, Connecticut, United States

Site Status

S320.2.011 Site # 505

Hollywood, Florida, United States

Site Status

S320.2.011 Site # 507

Jacksonville, Florida, United States

Site Status

S320.2.011 Site # 532

Riverdale, Georgia, United States

Site Status

S320.2.011 Site # 513

Chicago, Illinois, United States

Site Status

S320.2.011 Site # 561

Indianapolis, Indiana, United States

Site Status

S320.2.011 Site # 526

Owensboro, Kentucky, United States

Site Status

S320.2.011 Site # 504

Natchitoches, Louisiana, United States

Site Status

S320.2.011 Site # 546

Biddeford, Maine, United States

Site Status

S320.2.011 Site # 523

Dearborn, Michigan, United States

Site Status

S320.2.011 Site # 534

Detroit, Michigan, United States

Site Status

S320.2.011 Site # 558

Detroit, Michigan, United States

Site Status

S320.2.011 Site # 508

St Louis, Missouri, United States

Site Status

S320.2.011 Site # 541

Brooklyn, New York, United States

Site Status

S320.2.011 Site # 537

New York, New York, United States

Site Status

S320.2.011 Site # 521

Akron, Ohio, United States

Site Status

S320.2.011 Site # 527

Toledo, Ohio, United States

Site Status

S320.2.011 Site # 528

Philadelphia, Pennsylvania, United States

Site Status

S320.2.011 Site # 510

Colombia, South Carolina, United States

Site Status

S320.2.011 Site # 545

Nashville, Tennessee, United States

Site Status

S320.2.011 Site # 519

Tullahoma, Tennessee, United States

Site Status

S320.2.011 Site # 511

Houston, Texas, United States

Site Status

S320.2.011 Site # 518

San Antonio, Texas, United States

Site Status

S320.2.011 Site # 556

Manitowoc, Wisconsin, United States

Site Status

S320.2.011 Site # 565

Milwaukee, Wisconsin, United States

Site Status

S320.2.011 Site # 601

Montreal, , Canada

Site Status

S320.2.011 Site # 427

Santiago, , Chile

Site Status

S320.2.011 Site # 433

Viña del Mar, , Chile

Site Status

S320.2.011 Site # 434

Viña del Mar, , Chile

Site Status

S320.2.011 Site # 100

Aarhus, , Denmark

Site Status

S320.2.011 Site # 102

Aarhus, , Denmark

Site Status

S320.2.011 Site # 104

Copenhagen, , Denmark

Site Status

S320.2.011 Site # 103

Esbjerg, , Denmark

Site Status

S320.2.011 Site # 106

Frederiksberg, , Denmark

Site Status

S320.2.011 Site # 105

Herning, , Denmark

Site Status

S320.2.011 Site # 125

Dijon, , France

Site Status

S320.2.011 Site # 123

Lille, , France

Site Status

S320.2.011 Site # 121

Paris, , France

Site Status

S320.2.011 Site # 124

Pessac, , France

Site Status

S320.2.011 Site # 126

Pontoise, , France

Site Status

S320.2.011 Site # 128

Toulouse, , France

Site Status

S320.2.011 Site # 182

Bad Nauheim, , Germany

Site Status

S320.2.011 Site # 187

Berlin, , Germany

Site Status

S320.2.011 Site # 186

Frankfurt, , Germany

Site Status

S320.2.011 Site # 180

Hanover, , Germany

Site Status

S320.2.011 Site # 185

Limburg, , Germany

Site Status

S320.2.011 Site # 190

Mannheim, , Germany

Site Status

S320.2.011 Site # 188

Weiden, , Germany

Site Status

S320.2.011 Site # 146

Aosta, , Italy

Site Status

S320.2.011 Site # 145

Cremona, , Italy

Site Status

S320.2.011 Site # 142

Genova, , Italy

Site Status

S320.2.011 Site # 149

Milan, , Italy

Site Status

S320.2.011 Site # 140

Modena, , Italy

Site Status

S320.2.011 Site # 143

Orbassano, , Italy

Site Status

S320.2.011 Site # 250

Bialystok, , Poland

Site Status

S320.2.011 Site # 231

Inowrocław, , Poland

Site Status

S320.2.011 Site # 236

Krakow, , Poland

Site Status

S320.2.011 Site # 249

Lodz, , Poland

Site Status

S320.2.011 Site # 243

Oława, , Poland

Site Status

S320.2.011 Site # 240

Poznan, , Poland

Site Status

S320.2.011 Site # 247

Przeworsk, , Poland

Site Status

S320.2.011 Site # 242

Puławy, , Poland

Site Status

S320.2.011 Site # 251

Płock, , Poland

Site Status

S320.2.011 Site # 239

Radom, , Poland

Site Status

S320.2.011 Site # 232

Ruda Śląska, , Poland

Site Status

S320.2.011 Site # 245

Starogard Gdański, , Poland

Site Status

S320.2.011 Site # 234

Torun, , Poland

Site Status

S320.2.011 Site # 248

Torun, , Poland

Site Status

S320.2.011 Site # 238

Tychy, , Poland

Site Status

S320.2.011 Site # 233

Wroclaw, , Poland

Site Status

S320.2.011 Site # 265

Baia Mare, , Romania

Site Status

S320.2.011 Site # 262

Brăila, , Romania

Site Status

S320.2.011 Site # 260

Bucharest, , Romania

Site Status

S320.2.011 Site # 263

Bucharest, , Romania

Site Status

S320.2.011 Site # 267

Bucharest, , Romania

Site Status

S320.2.011 Site # 264

Suceava, , Romania

Site Status

S320.2.011 Site # 261

Târgovişte, , Romania

Site Status

S320.2.011 Site # 266

Timișoara, , Romania

Site Status

S320.2.011 Site # 294

Kazan', , Russia

Site Status

S320.2.011 Site # 306

Krasnodar, , Russia

Site Status

S320.2.011 Site # 290

Moscow, , Russia

Site Status

S320.2.011 Site # 297

Moscow, , Russia

Site Status

S320.2.011 Site # 299

Moscow, , Russia

Site Status

S320.2.011 Site # 301

Moscow, , Russia

Site Status

S320.2.011 Site # 303

Moscow, , Russia

Site Status

S320.2.011 Site # 304

Moscow, , Russia

Site Status

S320.2.011 Site # 305

Moscow, , Russia

Site Status

S320.2.011 Site # 291

Saint Petersburg, , Russia

Site Status

S320.2.011 Site # 292

Saint Petersburg, , Russia

Site Status

S320.2.011 Site # 298

Saint Petersburg, , Russia

Site Status

S320.2.011 Site # 300

Saint Petersburg, , Russia

Site Status

S320.2.011 Site # 302

Saint Petersburg, , Russia

Site Status

S320.2.011 Site # 293

Voronezh, , Russia

Site Status

S320.2.011 Site # 295

Yaroslavl, , Russia

Site Status

S320.2.011 Site # 335

Dnipropetrovsk, , Ukraine

Site Status

S320.2.011 Site # 332

Ivano-Frankivsk, , Ukraine

Site Status

S320.2.011 Site # 334

Kharkiv, , Ukraine

Site Status

S320.2.011 Site # 330

Kyiv, , Ukraine

Site Status

S320.2.011 Site # 338

Kyiv, , Ukraine

Site Status

S320.2.011 Site # 331

Luhansk, , Ukraine

Site Status

S320.2.011 Site # 333

Lutsk, , Ukraine

Site Status

S320.2.011 Site # 337

Odesa, , Ukraine

Site Status

Countries

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United States Canada Chile Denmark France Germany Italy Poland Romania Russia Ukraine

References

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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.

Reference Type DERIVED
PMID: 21641345 (View on PubMed)

Other Identifiers

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2008-003786-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

00744341

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

S320.2.011

Identifier Type: -

Identifier Source: org_study_id