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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003786-20 | EudraCT Number | ||
| 00744341 | Other Grant/Funding Number | NCT/NIH |
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This study was stopped 29OCT2009 due to strategic drug development considerations
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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.
The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
| |
| 5 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLV320 | Drug | 1.25mg i.v. bid |
| |
| SLV320 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum creatinine from baseline to Day 14 | Day 14 |
| Measure | Description | 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 | 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Robyn Bethany | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S320.2.011 Site # 548 | Alameda | California | United States | |||
| S320.2.011 Site # 566 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21641345 | Derived | 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. |
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| Drug |
3.75mg i.v. bid |
|
| SLV320 | Drug | 7.5mg i.v. bid |
|
| SLV320 | Drug | 15.0mg i.v. bid |
|
| Placebo | Drug |
|
| Up to Day 14 |
| To compare the effect of four I.V. doses of SLV320 with placebo on top of diuretic use | 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 | Up to Day 180 |
| To determine the pharmacokinetic profile of I.V. SLV320 | Up to Day 3 |
| Banning |
| California |
| United States |
| S320.2.011 Site # 551 | Inglewood | California | United States |
| S320.2.011 Site # 564 | Bridgeport | Connecticut | United States |
| S320.2.011 Site # 505 | Hollywood | Florida | United States |
| S320.2.011 Site # 507 | Jacksonville | Florida | United States |
| S320.2.011 Site # 532 | Riverdale | Georgia | United States |
| S320.2.011 Site # 513 | Chicago | Illinois | United States |
| S320.2.011 Site # 561 | Indianapolis | Indiana | United States |
| S320.2.011 Site # 526 | Owensboro | Kentucky | United States |
| S320.2.011 Site # 504 | Natchitoches | Louisiana | United States |
| S320.2.011 Site # 546 | Biddeford | Maine | United States |
| S320.2.011 Site # 523 | Dearborn | Michigan | United States |
| S320.2.011 Site # 534 | Detroit | Michigan | United States |
| S320.2.011 Site # 558 | Detroit | Michigan | United States |
| S320.2.011 Site # 508 | St Louis | Missouri | United States |
| S320.2.011 Site # 541 | Brooklyn | New York | United States |
| S320.2.011 Site # 537 | New York | New York | United States |
| S320.2.011 Site # 521 | Akron | Ohio | United States |
| S320.2.011 Site # 527 | Toledo | Ohio | United States |
| S320.2.011 Site # 528 | Philadelphia | Pennsylvania | United States |
| S320.2.011 Site # 510 | Colombia | South Carolina | United States |
| S320.2.011 Site # 545 | Nashville | Tennessee | United States |
| S320.2.011 Site # 519 | Tullahoma | Tennessee | United States |
| S320.2.011 Site # 511 | Houston | Texas | United States |
| S320.2.011 Site # 518 | San Antonio | Texas | United States |
| S320.2.011 Site # 556 | Manitowoc | Wisconsin | United States |
| S320.2.011 Site # 565 | Milwaukee | Wisconsin | United States |
| S320.2.011 Site # 601 | Montreal | Canada |
| S320.2.011 Site # 427 | Santiago | Chile |
| S320.2.011 Site # 433 | Viña del Mar | Chile |
| S320.2.011 Site # 434 | Viña del Mar | Chile |
| S320.2.011 Site # 100 | Aarhus | Denmark |
| S320.2.011 Site # 102 | Aarhus | Denmark |
| S320.2.011 Site # 104 | Copenhagen | Denmark |
| S320.2.011 Site # 103 | Esbjerg | Denmark |
| S320.2.011 Site # 106 | Frederiksberg | Denmark |
| S320.2.011 Site # 105 | Herning | Denmark |
| S320.2.011 Site # 125 | Dijon | France |
| S320.2.011 Site # 123 | Lille | France |
| S320.2.011 Site # 121 | Paris | France |
| S320.2.011 Site # 124 | Pessac | France |
| S320.2.011 Site # 126 | Pontoise | France |
| S320.2.011 Site # 128 | Toulouse | France |
| S320.2.011 Site # 182 | Bad Nauheim | Germany |
| S320.2.011 Site # 187 | Berlin | Germany |
| S320.2.011 Site # 186 | Frankfurt | Germany |
| S320.2.011 Site # 180 | Hanover | Germany |
| S320.2.011 Site # 185 | Limburg | Germany |
| S320.2.011 Site # 190 | Mannheim | Germany |
| S320.2.011 Site # 188 | Weiden | Germany |
| S320.2.011 Site # 146 | Aosta | Italy |
| S320.2.011 Site # 145 | Cremona | Italy |
| S320.2.011 Site # 142 | Genova | Italy |
| S320.2.011 Site # 149 | Milan | Italy |
| S320.2.011 Site # 140 | Modena | Italy |
| S320.2.011 Site # 143 | Orbassano | Italy |
| S320.2.011 Site # 250 | Bialystok | Poland |
| S320.2.011 Site # 231 | Inowrocław | Poland |
| S320.2.011 Site # 236 | Krakow | Poland |
| S320.2.011 Site # 249 | Lodz | Poland |
| S320.2.011 Site # 243 | Oława | Poland |
| S320.2.011 Site # 240 | Poznan | Poland |
| S320.2.011 Site # 247 | Przeworsk | Poland |
| S320.2.011 Site # 242 | Puławy | Poland |
| S320.2.011 Site # 251 | Płock | Poland |
| S320.2.011 Site # 239 | Radom | Poland |
| S320.2.011 Site # 232 | Ruda Śląska | Poland |
| S320.2.011 Site # 245 | Starogard Gdański | Poland |
| S320.2.011 Site # 234 | Torun | Poland |
| S320.2.011 Site # 248 | Torun | Poland |
| S320.2.011 Site # 238 | Tychy | Poland |
| S320.2.011 Site # 233 | Wroclaw | Poland |
| S320.2.011 Site # 265 | Baia Mare | Romania |
| S320.2.011 Site # 262 | Brăila | Romania |
| S320.2.011 Site # 260 | Bucharest | Romania |
| S320.2.011 Site # 263 | Bucharest | Romania |
| S320.2.011 Site # 267 | Bucharest | Romania |
| S320.2.011 Site # 264 | Suceava | Romania |
| S320.2.011 Site # 261 | Targoviste | Romania |
| S320.2.011 Site # 266 | Timișoara | Romania |
| S320.2.011 Site # 294 | Kazan' | Russia |
| S320.2.011 Site # 306 | Krasnodar | Russia |
| S320.2.011 Site # 290 | Moscow | Russia |
| S320.2.011 Site # 297 | Moscow | Russia |
| S320.2.011 Site # 299 | Moscow | Russia |
| S320.2.011 Site # 301 | Moscow | Russia |
| S320.2.011 Site # 303 | Moscow | Russia |
| S320.2.011 Site # 304 | Moscow | Russia |
| S320.2.011 Site # 305 | Moscow | Russia |
| S320.2.011 Site # 291 | Saint Petersburg | Russia |
| S320.2.011 Site # 292 | Saint Petersburg | Russia |
| S320.2.011 Site # 298 | Saint Petersburg | Russia |
| S320.2.011 Site # 300 | Saint Petersburg | Russia |
| S320.2.011 Site # 302 | Saint Petersburg | Russia |
| S320.2.011 Site # 293 | Voronezh | Russia |
| S320.2.011 Site # 295 | Yaroslavl | Russia |
| S320.2.011 Site # 335 | Dnipropetrovsk | Ukraine |
| S320.2.011 Site # 332 | Ivano-Frankivsk | Ukraine |
| S320.2.011 Site # 334 | Kharkiv | Ukraine |
| S320.2.011 Site # 330 | Kyiv | Ukraine |
| S320.2.011 Site # 338 | Kyiv | Ukraine |
| S320.2.011 Site # 331 | Luhansk | Ukraine |
| S320.2.011 Site # 333 | Lutsk | Ukraine |
| S320.2.011 Site # 337 | Odesa | Ukraine |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C523961 | SLV320 compound |
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