Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Sequential Cohort Study to Evaluate the Effect of SLV320 in Addition to Chronic Furosemide Treatment on Renal Function in Subjects With Congestive Heart Failure and Impaired Renal Function

Solvay Pharmaceuticals72 sites in 7 countries300 target enrollmentStarted: October 2007Last updated: April 22, 2008

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Terminated
Sponsor: Solvay Pharmaceuticals
Enrollment: 300
Locations: 72
Primary Endpoint: Cystatine C

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

This is a randomized, double-blind, placebo-controlled, multi-center, sequential cohort study in subjects with congestive heart failure (CHF) and impaired renal function who are on stable furosemide treatment (³ 40 mg daily). A total of 50 subjects will be randomized to each increasing dose level of SLV320 or placebo in a sequential fashion.

Study Design

Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Eligibility Criteria

Ages: 18 Years to 85 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•Male and female subjects aged 18 to85 years who gave written informed consent.
•Subjects must have a history of chronic, symptomatic, New York Heart Association (NYHA) Class II-III CHF and impaired renal function (baseline eGFR of 20 to 75 mL/min/1.73m2).
•Congestive heart failure should have been diagnosed at least 3 months before Visit 1 (Day 1) and the subjects should be on chronic treatment with furosemide (40 mg daily) for at least 3 weeks before Visit 1 (Day 1).
•Subjects must be on stable doses of their individually optimized medication regimen for at least 4 weeks before Visit 1 (Day 1).

Exclusion Criteria

•Any history of a convulsive disorder or pre-convulsive state and any risk for a convulsive disorder or pre-convulsive state (for example any past brain trauma, abuse of alcohol) will lead to an exclusion from the study.
•Females of childbearing potential not using specified contraception, subjects with malignant tumors with a short life expectancy, subjects with known severe reactions to drugs and subjects with bilateral renal artery stenosis will be excluded from the study.

Outcomes

Primary Outcomes

Cystatine C

Time Frame: 3 months

Secondary Outcomes

Sodium in urine(3 months)
Clinical global impression(3 months)
Body weight(3 months)
Estimated glomerular filtration rate(3 months)

Investigators

Sponsor

Solvay Pharmaceuticals

Sponsor Class

Industry

Study Sites (72)

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