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

Terminated

• Conditions: Congestive Heart Failure

• Registration Number: NCT00568009
• Lead Sponsor: Solvay Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-04
• Study First Posted: 2007-12-05
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-18
• Last Update Posted: 2008-04-22
• Primary Completion: 2008-11
• Study Completion: 2008-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cystatine C	3 months

Secondary Outcome Measures

Name	Time	Method
Clinical global impression	3 months
Body weight	3 months
Estimated glomerular filtration rate	3 months
Sodium in urine	3 months

Trial Locations

Locations (72)

Site 96; 🇺🇸 Whittier, California, United States

Site 95; 🇺🇸 Largo, Florida, United States

Site 90; 🇺🇸 Miami, Florida, United States

Site 88; 🇺🇸 Atlanta, Georgia, United States

Site 92; 🇺🇸 Covington, Georgia, United States

Site 106; 🇺🇸 Melrose Park, Illinois, United States

Site 87; 🇺🇸 Hagerstown, Maryland, United States

Site 94; 🇺🇸 Springfield Gardens, New York, United States

Site 89; 🇺🇸 Dallas, Texas, United States

Site 97; 🇺🇸 San Antonio, Texas, United States

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