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
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 300
- 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).
- 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 90
🇺🇸Miami, Florida, United States
Site 11
🇦🇷Bahia Blanca, Argentina
Site 6
🇦🇷Coronel Suarez, Argentina
Site 50
🇵🇱Bydgoszcz, Poland
Site 75
🇿🇦Belville, South Africa
Site 73
🇿🇦Kempton Park, South Africa
Site 71
🇿🇦Somerset West, South Africa
Site 106
🇺🇸Melrose Park, Illinois, United States
Site 104
🇦🇷Mar del Plata, Argentina
Site 95
🇺🇸Largo, Florida, United States
Site 92
🇺🇸Covington, Georgia, United States
Site 2
🇦🇷Bahia Blanca, Argentina
Site 1
🇦🇷Corrientes, Argentina
Site 5
🇦🇷La Plata, Argentina
Site 20
🇨🇿Praha, Czech Republic
Site 21
🇨🇿Praha, Czech Republic
Site 96
🇺🇸Whittier, California, United States
Site 94
🇺🇸Springfield Gardens, New York, United States
Site 105
🇦🇷San Luis, Argentina
Site 4
🇦🇷San Martin, Argentina
Site 8
🇦🇷Santa Fe, Argentina
Site 14
🇧🇪Antwerpen, Belgium
Site 22
🇨🇿Brno, Czech Republic
Site 19
🇨🇿Kromeriz, Czech Republic
Site 65
Belgrade, Former Serbia and Montenegro
Site 67
Sremska Kamenica, Former Serbia and Montenegro
Site 26
🇩🇪Dortmund, Germany
Site 57
🇵🇱Skierniewice, Poland
Site 54
🇵🇱Torun, Poland
Site 51
🇵🇱Zielona Gora, Poland
Site 59
🇷🇺Samara, Russian Federation
Site 72
🇿🇦Belville, South Africa
Site 97
🇺🇸San Antonio, Texas, United States
Site 64
🇷🇺Moscow, Russian Federation
Site 101
🇦🇷Capital Federal, Argentina
Site 102
🇦🇷Salta, Argentina
Site 15
🇧🇪Gent, Belgium
Site 88
🇺🇸Atlanta, Georgia, United States
Site 16
🇨🇿Jindrichuv Hradec, Czech Republic
Site 17
🇨🇿Semily, Czech Republic
Site 69
Belgrade, Former Serbia and Montenegro
Site 55
🇵🇱Wroclaw, Poland
Site 87
🇺🇸Hagerstown, Maryland, United States
Site 60
🇷🇺saint-Petersburg, Russian Federation
Site 98
🇿🇦Durban, South Africa
Site 77
🇪🇸Malaga, Spain
Site 79
🇪🇸Madrid, Spain
Site 89
🇺🇸Dallas, Texas, United States
Site 61
🇷🇺Moscow, Russian Federation
Site 62
🇷🇺Moscow, Russian Federation
Site 78
🇪🇸Barcelona, Spain
Site 12
🇧🇪Huy, Belgium
Site 23
🇨🇿Teplice, Czech Republic
Site 66
Belgrade, Former Serbia and Montenegro
Site 68
Niska Banja, Former Serbia and Montenegro
Site 52
🇵🇱Warszawa, Poland
Site 53
🇵🇱Warszawa, Poland
Site 56
🇵🇱Warszawa, Poland
Site 28
🇩🇪Berlin, Germany
Site 58
🇷🇺Moscow, Russian Federation
Site 18
🇨🇿Slany, Czech Republic
Site 70
Zemun, Former Serbia and Montenegro
Site 24
🇩🇪Bad Nauheim, Germany
Site 47
🇵🇱Lublin, Poland
Site 49
🇵🇱Plock, Poland
Site 48
🇵🇱Warszawa, Poland
Site 76
🇿🇦Bloemfontein, South Africa
Site 63
🇷🇺Moscow, Russian Federation
Site 80
🇪🇸Valencia, Spain
Site 74
🇿🇦Worcester, South Africa
Site 82
🇪🇸Santander, Spain
Site 83
🇪🇸Barcelona, Spain