Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Decompensated Heart Failure; Renal Dysfunction

Keywords

SLV320; Acute Decompensated Heart Failure (ADHF); chronic heart failure; renal failure; I.V. doses; hospitalization

Outcome Measures

Primary Outcomes (1)

Change in serum creatinine from baseline to Day 14
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
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
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

Study Arms (5)

1

EXPERIMENTAL

Drug: SLV320

2

EXPERIMENTAL

Drug: SLV320

3

EXPERIMENTAL

Drug: SLV320

4

EXPERIMENTAL

Interventions

SLV320Drug

1.25mg i.v. bid

SLV320Drug

3.75mg i.v. bid

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Solvay Pharmaceuticals
Industrylead

Study Sites (105)

S320.2.011 Site # 548

Alameda, California, United States

S320.2.011 Site # 566

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

Related Publications (1)

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.
PMID: 21641345DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

SLV320 compound

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

Robyn Bethany
Solvay Pharmaceuticals
STUDY DIRECTOR

Enrollment

46 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

August 28, 2008

First Posted

August 29, 2008

Study Start

February 2009

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (5)

1

2

3

4

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (105)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

5

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (5)

1

2

3

4

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (105)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

5

Source record

Locations