Acute Decompensated Heart Failure; Renal Dysfunction Clinical Trial
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)
| Verified date | September 2010 |
| Source | Solvay Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.
| Status | Terminated |
| Enrollment | 46 |
| Est. completion date | January 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | S320.2.011 Site # 601 | Montreal | |
| Chile | S320.2.011 Site # 427 | Santiago | |
| Chile | S320.2.011 Site # 433 | Viña del Mar | |
| Chile | S320.2.011 Site # 434 | Viña del Mar | |
| Denmark | S320.2.011 Site # 100 | Aarhus | |
| Denmark | S320.2.011 Site # 102 | Aarhus | |
| 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 # 104 | København | |
| France | 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 | |
| Germany | 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 | Hannover | |
| Germany | S320.2.011 Site # 185 | Limburg | |
| Germany | S320.2.011 Site # 190 | Mannheim | |
| Germany | S320.2.011 Site # 188 | Weiden | |
| Italy | 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 | Milano | |
| Italy | S320.2.011 Site # 140 | Modena | |
| Italy | S320.2.011 Site # 143 | Orbassano | |
| Poland | S320.2.011 Site # 250 | Bialystok | |
| Poland | S320.2.011 Site # 231 | Inowroclaw | |
| Poland | S320.2.011 Site # 236 | Krakow | |
| Poland | S320.2.011 Site # 249 | Lodz | |
| Poland | S320.2.011 Site # 243 | Olawa | |
| Poland | S320.2.011 Site # 251 | Plock | |
| Poland | S320.2.011 Site # 240 | Poznan | |
| Poland | S320.2.011 Site # 247 | Przeworsk | |
| Poland | S320.2.011 Site # 242 | Pulawy | |
| Poland | S320.2.011 Site # 239 | Radom | |
| Poland | S320.2.011 Site # 232 | Ruda Slaska | |
| Poland | S320.2.011 Site # 245 | Starogard Gdanski | |
| 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 | |
| Romania | S320.2.011 Site # 265 | Baia Mare | |
| Romania | S320.2.011 Site # 262 | Braila | |
| Romania | S320.2.011 Site # 260 | Bucuresti | |
| Romania | S320.2.011 Site # 263 | Bucuresti | |
| Romania | S320.2.011 Site # 267 | Bucuresti | |
| Romania | S320.2.011 Site # 264 | Suceava | |
| Romania | S320.2.011 Site # 261 | Targoviste | |
| Romania | S320.2.011 Site # 266 | Timisoara | |
| Russian Federation | S320.2.011 Site # 294 | Kazan | |
| Russian Federation | S320.2.011 Site # 306 | Krasnodar | |
| 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 | Moscow | |
| 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 | Saint-Petersburg | |
| Russian Federation | S320.2.011 Site # 300 | St. Petersburg | |
| Russian Federation | S320.2.011 Site # 293 | Voronezh | |
| Russian Federation | S320.2.011 Site # 295 | Yaroslavl | |
| Ukraine | 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 | Lugansk | |
| Ukraine | S320.2.011 Site # 333 | Lutsk | |
| Ukraine | S320.2.011 Site # 337 | Odessa | |
| United States | S320.2.011 Site # 521 | Akron | Ohio |
| United States | S320.2.011 Site # 548 | Alameda | California |
| United States | S320.2.011 Site # 566 | Banning | California |
| United States | S320.2.011 Site # 546 | Biddeford | Maine |
| United States | S320.2.011 Site # 564 | Bridgeport | Connecticut |
| United States | S320.2.011 Site # 541 | Brooklyn | New York |
| United States | S320.2.011 Site # 513 | Chicago | Illinois |
| United States | S320.2.011 Site # 510 | Colombia | South Carolina |
| 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 # 505 | Hollywood | Florida |
| United States | S320.2.011 Site # 511 | Houston | Texas |
| United States | S320.2.011 Site # 561 | Indianapolis | Indiana |
| United States | S320.2.011 Site # 551 | Inglewood | California |
| United States | S320.2.011 Site # 507 | Jacksonville | Florida |
| United States | S320.2.011 Site # 556 | Manitowoc | Wisconsin |
| United States | S320.2.011 Site # 565 | Milwaukee | Wisconsin |
| United States | S320.2.011 Site # 545 | Nashville | Tennessee |
| United States | S320.2.011 Site # 504 | Natchitoches | Louisiana |
| United States | S320.2.011 Site # 537 | New York | New York |
| United States | S320.2.011 Site # 526 | Owensboro | Kentucky |
| United States | S320.2.011 Site # 528 | Philadelphia | Pennsylvania |
| United States | S320.2.011 Site # 532 | Riverdale | Georgia |
| United States | S320.2.011 Site # 518 | San Antonio | Texas |
| United States | S320.2.011 Site # 508 | St. Louis | Missouri |
| United States | S320.2.011 Site # 527 | Toledo | Ohio |
| United States | S320.2.011 Site # 519 | Tullahoma | Tennessee |
| Lead Sponsor | Collaborator |
|---|---|
| Solvay Pharmaceuticals |
United States, Canada, Chile, Denmark, France, Germany, Italy, Poland, Romania, Russian Federation, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in serum creatinine from baseline to Day 14 | Day 14 | No | |
| Secondary | 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) | No | |
| Secondary | 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 | Up to Day 14 | No | |
| Secondary | To compare the effect of four I.V. doses of SLV320 with placebo on top of diuretic use | Up to Day 3 | No | |
| Secondary | 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 | Yes | |
| Secondary | To determine the pharmacokinetic profile of I.V. SLV320 | Up to Day 3 | No |