Heart Failure Clinical Trial
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
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.
Eligibility 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.
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There is 1 Location for this study
Whittier California, , United States
Largo Florida, , United States
Miami Florida, , United States
Atlanta Georgia, , United States
Covington Georgia, , United States
Melrose Park Illinois, , United States
Hagerstown Maryland, , United States
Springfield Gardens New York, , United States
Dallas Texas, , United States
San Antonio Texas, , United States
Bahia Blanca , , Argentina
Bahia Blanca , , Argentina
Capital Federal , , Argentina
Coronel Suarez , , Argentina
Corrientes , , Argentina
La Plata , , Argentina
Mar del Plata , , Argentina
Salta , , Argentina
San Luis , , Argentina
San Martin , , Argentina
Santa Fe , , Argentina
Antwerpen , , Belgium
Gent , , Belgium
Huy , , Belgium
Brno , , Czech Republic
Jindrichuv Hradec , , Czech Republic
Kromeriz , , Czech Republic
Praha , , Czech Republic
Praha , , Czech Republic
Semily , , Czech Republic
Slany , , Czech Republic
Teplice , , Czech Republic
Belgrade , , Former Serbia and Montenegro
Belgrade , , Former Serbia and Montenegro
Belgrade , , Former Serbia and Montenegro
Niska Banja , , Former Serbia and Montenegro
Sremska Kamenica , , Former Serbia and Montenegro
Zemun , , Former Serbia and Montenegro
Bad Nauheim , , Germany
Berlin , , Germany
Dortmund , , Germany
Bydgoszcz , , Poland
Lublin , , Poland
Plock , , Poland
Skierniewice , , Poland
Torun , , Poland
Warszawa , , Poland
Warszawa , , Poland
Warszawa , , Poland
Warszawa , , Poland
Wroclaw , , Poland
Zielona Gora , , Poland
Moscow , , Russian Federation
Moscow , , Russian Federation
Moscow , , Russian Federation
Moscow , , Russian Federation
Moscow , , Russian Federation
saint-Petersburg , , Russian Federation
Samara , , Russian Federation
Belville , , South Africa
Belville , , South Africa
Bloemfontein , , South Africa
Durban , , South Africa
Kempton Park , , South Africa
Somerset West , , South Africa
Worcester , , South Africa
Barcelona , , Spain
Barcelona , , Spain
Madrid , , Spain
Malaga , , Spain
Santander , , Spain
Valencia , , Spain
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