Official Title: “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”

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 Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: SLV320
  • 1, 2.5, 5, 10 and 20 mg twice daily and placebo group. Duration of treatment 84 days

Primary Measures

• Cystatine C
  • Time Frame: 3 months
    Safety Issue?: No

Secondary Measures

• Sodium in urine
  • Time Frame: 3 months
    Safety Issue?: No
• Estimated glomerular filtration rate
  • Time Frame: 3 months
    Safety Issue?: No
• Clinical global impression
  • Time Frame: 3 months
    Safety Issue?: No
• Body weight
  • Time Frame: 3 months
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Solvay Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Global Clinical Director Solvay Study Director Solvay Pharmaceuticals  

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00568009

Study ID Number: S320.2.003

ClinicalTrials.gov Identifier: NCT00568009

Health Authority: United States: Food and Drug Administration