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

Condition(s) targeted: Congestive Heart Failure

Intervention: SLV320 (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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.

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

Study design: Cohort, Prospective

Primary outcome: Cystatine C

Secondary outcome:

Sodium in urine

Estimated glomerular filtration rate

Clinical global impression

Body weight

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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.

Site 11, Bahia Blanca, Argentina

Site 4, San Martin, Argentina

Site 5, La Plata, Argentina

Site 6, Coronel Suarez, Argentina

Site 8, Santa Fe, Argentina

Site 2, Bahia Blanca, Argentina

Site 101, Capital Federal, Argentina

Site 102, Salta, Argentina

Site 104, Mar del Plata, Argentina

Site 1, Corrientes, Argentina

Site 105, San Luis, Argentina

Site 12, Huy, Belgium

Site 14, Antwerpen, Belgium

Site 15, Gent, Belgium

Site 16, Jindrichuv Hradec, Czech Republic

Site 17, Semily, Czech Republic

Site 18, Slany, Czech Republic

Site 19, Kromeriz, Czech Republic

Site 20, Praha, Czech Republic

Site 21, Praha, Czech Republic

Site 22, Brno, Czech Republic

Site 23, Teplice, Czech Republic

Site 28, Berlin, Germany

Site 26, Dortmund, Germany

Site 24, Bad Nauheim, Germany

Site 47, Lublin, Poland

Site 48, Warszawa, Poland

Site 49, Plock, Poland

Site 50, Bydgoszcz, Poland

Site 51, Zielona Gora, Poland

Site 52, Warszawa, Poland

Site 53, Warszawa, Poland

Site 54, Torun, Poland

Site 55, Wroclaw, Poland

Site 56, Warszawa, Poland

Site 57, Skierniewice, Poland

Site 58, Moscow, Russian Federation

Site 59, Samara, Russian Federation

Site 60, saint-Petersburg, Russian Federation

Site 61, Moscow, Russian Federation

Site 62, Moscow, Russian Federation

Site 63, Moscow, Russian Federation

Site 64, Moscow, Russian Federation

Site 65, Belgrade, Serbia and Montenegro

Site 66, Belgrade, Serbia and Montenegro

Site 69, Belgrade, Serbia and Montenegro

Site 70, Zemun, Serbia and Montenegro

Site 68, Niska Banja, Serbia and Montenegro

Site 67, Sremska Kamenica, Serbia and Montenegro

Site 72, Belville, South Africa

Site 71, Somerset West, South Africa

Site 73, Kempton Park, South Africa

Site 74, Worcester, South Africa

Site 76, Bloemfontein, South Africa

Site 75, Belville, South Africa

Site 98, Durban, South Africa

Site 83, Barcelona, Spain

Site 79, Madrid, Spain

Site 80, Valencia, Spain

Site 82, Santander, Spain

Site 78, Barcelona, Spain

Site 77, Malaga, Spain

Site 96, Whittier, California, United States

Site 90, Miami, Florida, United States

Site 95, Largo, 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

Starting date: October 2007
Ending date: November 2008
Last updated: April 18, 2008