Acute Decompensated Heart Failure; Renal DysfunctionPhase 2NCT00744341
Safety and Efficacy Study to Evaluate the Effect of SLV320 on Renal Function in Patients With Worsening Heart Failure
A Phase 2 study testing SLV320 in people with Acute Decompensated Heart Failure; Renal Dysfunction, run by Solvay Pharmaceuticals at 105 sites in 11 countries.
Trial summary
The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure; Renal Dysfunction
- What is being tested?
- SLV320
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 105 sitesin 11 countries
- Study dates
- Feb 2009to Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
105 sites in 11 countries.
105 sites in 11 countries
United States28 sites
S320.2.011 Site # 521
Akron, Ohio
S320.2.011 Site # 548
Alameda, California
S320.2.011 Site # 566
Banning, California
S320.2.011 Site # 546
Biddeford, Maine
S320.2.011 Site # 564
Bridgeport, Connecticut
S320.2.011 Site # 541
Brooklyn, New York
S320.2.011 Site # 513
Chicago, Illinois
S320.2.011 Site # 510
Colombia, South Carolina
S320.2.011 Site # 523
Dearborn, Michigan
S320.2.011 Site # 534
Detroit, Michigan
S320.2.011 Site # 558
Detroit, Michigan
S320.2.011 Site # 505
Hollywood, Florida
S320.2.011 Site # 511
Houston, Texas
S320.2.011 Site # 561
Indianapolis, Indiana
S320.2.011 Site # 551
Inglewood, California
S320.2.011 Site # 507
Jacksonville, Florida
S320.2.011 Site # 556
Manitowoc, Wisconsin
S320.2.011 Site # 565
Milwaukee, Wisconsin
S320.2.011 Site # 545
Nashville, Tennessee
S320.2.011 Site # 504
Natchitoches, Louisiana
S320.2.011 Site # 537
New York, New York
S320.2.011 Site # 526
Owensboro, Kentucky
S320.2.011 Site # 528
Philadelphia, Pennsylvania
S320.2.011 Site # 532
Riverdale, Georgia
S320.2.011 Site # 518
San Antonio, Texas
S320.2.011 Site # 508
St Louis, Missouri
S320.2.011 Site # 527
Toledo, Ohio
S320.2.011 Site # 519
Tullahoma, Tennessee
Poland16 sites
S320.2.011 Site # 250
Bialystok
S320.2.011 Site # 231
Inowrocław
S320.2.011 Site # 236
Krakow
S320.2.011 Site # 249
Lodz
S320.2.011 Site # 243
Oława
S320.2.011 Site # 251
Płock
S320.2.011 Site # 240
Poznan
S320.2.011 Site # 247
Przeworsk
S320.2.011 Site # 242
Puławy
S320.2.011 Site # 239
Radom
S320.2.011 Site # 232
Ruda Śląska
S320.2.011 Site # 245
Starogard Gdański
S320.2.011 Site # 234
Torun
S320.2.011 Site # 248
Torun
S320.2.011 Site # 238
Tychy
S320.2.011 Site # 233
Wroclaw
Russia16 sites
S320.2.011 Site # 294
Kazan'
S320.2.011 Site # 306
Krasnodar
S320.2.011 Site # 290
Moscow
S320.2.011 Site # 297
Moscow
S320.2.011 Site # 299
Moscow
S320.2.011 Site # 301
Moscow
S320.2.011 Site # 303
Moscow
S320.2.011 Site # 304
Moscow
S320.2.011 Site # 305
Moscow
S320.2.011 Site # 291
Saint Petersburg
S320.2.011 Site # 292
Saint Petersburg
S320.2.011 Site # 298
Saint Petersburg
S320.2.011 Site # 300
Saint Petersburg
S320.2.011 Site # 302
Saint Petersburg
S320.2.011 Site # 293
Voronezh
S320.2.011 Site # 295
Yaroslavl
Romania8 sites
S320.2.011 Site # 265
Baia Mare
S320.2.011 Site # 262
Brăila
S320.2.011 Site # 260
Bucharest
S320.2.011 Site # 263
Bucharest
S320.2.011 Site # 267
Bucharest
S320.2.011 Site # 264
Suceava
S320.2.011 Site # 261
Targoviste
S320.2.011 Site # 266
Timișoara
Ukraine8 sites
S320.2.011 Site # 335
Dnipropetrovsk
S320.2.011 Site # 332
Ivano-Frankivsk
S320.2.011 Site # 334
Kharkiv
S320.2.011 Site # 330
Kyiv
S320.2.011 Site # 338
Kyiv
S320.2.011 Site # 331
Luhansk
S320.2.011 Site # 333
Lutsk
S320.2.011 Site # 337
Odesa
Germany7 sites
S320.2.011 Site # 182
Bad Nauheim
S320.2.011 Site # 187
Berlin
S320.2.011 Site # 186
Frankfurt
S320.2.011 Site # 180
Hanover
S320.2.011 Site # 185
Limburg
S320.2.011 Site # 190
Mannheim
S320.2.011 Site # 188
Weiden
Denmark6 sites
S320.2.011 Site # 100
Aarhus
S320.2.011 Site # 102
Aarhus
S320.2.011 Site # 104
Copenhagen
S320.2.011 Site # 103
Esbjerg
S320.2.011 Site # 106
Frederiksberg
S320.2.011 Site # 105
Herning
France6 sites
S320.2.011 Site # 125
Dijon
S320.2.011 Site # 123
Lille
S320.2.011 Site # 121
Paris
S320.2.011 Site # 124
Pessac
S320.2.011 Site # 126
Pontoise
S320.2.011 Site # 128
Toulouse
Italy6 sites
S320.2.011 Site # 146
Aosta
S320.2.011 Site # 145
Cremona
S320.2.011 Site # 142
Genova
S320.2.011 Site # 149
Milan
S320.2.011 Site # 140
Modena
S320.2.011 Site # 143
Orbassano
Chile3 sites
S320.2.011 Site # 427
Santiago
S320.2.011 Site # 433
Viña del Mar
S320.2.011 Site # 434
Viña del Mar
About this study
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)
The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.
Read the 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.
- Being tested
- SLV320, Placebo
- Keywords
- SLV320; Acute Decompensated Heart Failure (ADHF); chronic heart failure; renal failure; I.V. doses; hospitalization
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLV320Drug
1.25mg i.v. bid
SLV320Drug
3.75mg i.v. bid
SLV320Drug
7.5mg i.v. bid
SLV320Drug
15.0mg i.v. bid
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: SLV320 |
| 2 | Experimental | Not described Receives: Drug: SLV320 |
| 3 | Experimental | Not described Receives: Drug: SLV320 |
| 4 | Experimental | Not described Receives: Drug: SLV320 |
| 5 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum creatinine from baseline to Day 14
Measured: Day 14
Secondary outcomes (5)
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
Measured: 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
Measured: Up to Day 14
To compare the effect of four I.V. doses of SLV320 with placebo on top of diuretic use
Measured: 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
Measured: Up to Day 180
To determine the pharmacokinetic profile of I.V. SLV320
Measured: Up to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: This study was stopped 29OCT2009 due to strategic drug development considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Decompensated Heart Failure; Renal DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robyn Bethany, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744341
- Sponsor's protocol ID
- S320.2.011
- Other IDs
- 2008-003786-20, 00744341, 2008
- Status last verified
- Sep 2010
- First submitted
- 28 Aug 2008
- Last updated
- 17 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21641345
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00744341
- Acronym / sponsor ID
- S320.2.011
- Keywords
- SLV320; Acute Decompensated Heart Failure (ADHF); chronic heart failure; renal failure; I.V. doses; hospitalization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was stopped 29OCT2009 due to strategic drug development considerations
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SLV320 |
| 2 | Experimental | Drug: SLV320 |
| 3 | Experimental | Drug: SLV320 |
| 4 | Experimental | Drug: SLV320 |
| 5 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLV3201.25mg i.v. bid | Drug | 1 |
| SLV3203.75mg i.v. bid | Drug | 2 |
| SLV3207.5mg i.v. bid | Drug | 3 |
| SLV32015.0mg i.v. bid | Drug | 4 |
| Placebo | Drug | 5 |
Primary outcome
Change in serum creatinine from baseline to Day 14
Time frame: Day 14
5 secondary outcomes
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)
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
To compare the effect of four I.V. doses of SLV320 with placebo on top of diuretic use
Time frame: 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
To determine the pharmacokinetic profile of I.V. SLV320
Time frame: Up to Day 3
Results and safety
The study was stopped early (reason given: This study was stopped 29OCT2009 due to strategic drug development considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2010.
- Derived from this study: PubMed 21641345Pang 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.
Related trials for Acute Decompensated Heart Failure; Renal Dysfunction
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Heart Decompensation, Acute, Acute Kidney Injuries
Not yet recruiting
Efficacy and Safety of Compression Boots in Patients With Acute Decompensated Heart Failure.
Acute Decompensated Heart Failure (ADHF)
RecruitingObservational study
Loop Diuretic Therapy in Acutely Decompensated Heart Failure
Acute Heart Failure
Recruiting
Venous Ultrasound Guided Organ Decongestion in Patients Hospitalized with Acute Decompensated Heart Failure
Cardiorenal Syndrome, Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn Bethany study director
Solvay Pharmaceuticals
105 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SLV320 in people with Acute Decompensated Heart Failure; Renal Dysfunction, run by Solvay Pharmaceuticals at 105 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 105 sites in United States, Poland, Russia, Romania, Ukraine and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study was stopped 29OCT2009 due to strategic drug development considerations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum creatinine from baseline to Day 14 (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00744341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2010.