Clinical trial NCT00568009: 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
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congestive Heart Failure
Keywords: Congestive Heart Failure
Impaired Renal Function
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2007-12-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Study population: Congestive Heart Failure, Impaired Renal Function

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.


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.

Primary outcomes:
measure: Cystatine C
timeFrame: 3 months
Secondary outcomes:
measure: Sodium in urine
timeFrame: 3 months
measure: Estimated glomerular filtration rate
timeFrame: 3 months
measure: Clinical global impression
timeFrame: 3 months
measure: Body weight
timeFrame: 3 months
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Site 96
state: California
city: Largo
country: United States
facility: Site 95
state: Florida
city: Miami
country: United States
facility: Site 90
state: Florida
city: Atlanta
country: United States
facility: Site 88
state: Georgia
city: Covington
country: United States
facility: Site 92
state: Georgia
city: Melrose Park
country: United States
facility: Site 106
state: Illinois
city: Hagerstown
country: United States
facility: Site 87
state: Maryland
city: Springfield Gardens
country: United States
facility: Site 94
state: New York
city: Dallas
country: United States
facility: Site 89
state: Texas
city: San Antonio
country: United States
facility: Site 97
state: Texas
city: Bahia Blanca
country: Argentina
facility: Site 11
city: Bahia Blanca
country: Argentina
facility: Site 2
city: Capital Federal
country: Argentina
facility: Site 101
city: Coronel Suarez
country: Argentina
facility: Site 6
city: Corrientes
country: Argentina
facility: Site 1
city: La Plata
country: Argentina
facility: Site 5
city: Mar del Plata
country: Argentina
facility: Site 104
city: Salta
country: Argentina
facility: Site 102
city: San Luis
country: Argentina
facility: Site 105
city: San Martin
country: Argentina
facility: Site 4
city: Santa Fe
country: Argentina
facility: Site 8
city: Antwerpen
country: Belgium
facility: Site 14
city: Gent
country: Belgium
facility: Site 15
city: Huy
country: Belgium
facility: Site 12
city: Brno
country: Czech Republic
facility: Site 22
city: Jindrichuv Hradec
country: Czech Republic
facility: Site 16
city: Kromeriz
country: Czech Republic
facility: Site 19
city: Praha
country: Czech Republic
facility: Site 20
city: Praha
country: Czech Republic
facility: Site 21
city: Semily
country: Czech Republic
facility: Site 17
city: Slany
country: Czech Republic
facility: Site 18
city: Teplice
country: Czech Republic
facility: Site 23
city: Belgrade
country: Former Serbia and Montenegro
facility: Site 65
city: Belgrade
country: Former Serbia and Montenegro
facility: Site 66
city: Belgrade
country: Former Serbia and Montenegro
facility: Site 69
city: Niska Banja
country: Former Serbia and Montenegro
facility: Site 68
city: Sremska Kamenica
country: Former Serbia and Montenegro
facility: Site 67
city: Zemun
country: Former Serbia and Montenegro
facility: Site 70
city: Bad Nauheim
country: Germany
facility: Site 24
city: Berlin
country: Germany
facility: Site 28
city: Dortmund
country: Germany
facility: Site 26
city: Bydgoszcz
country: Poland
facility: Site 50
city: Lublin
country: Poland
facility: Site 47
city: Plock
country: Poland
facility: Site 49
city: Skierniewice
country: Poland
facility: Site 57
city: Torun
country: Poland
facility: Site 54
city: Warszawa
country: Poland
facility: Site 48
city: Warszawa
country: Poland
facility: Site 52
city: Warszawa
country: Poland
facility: Site 53
city: Warszawa
country: Poland
facility: Site 56
city: Wroclaw
country: Poland
facility: Site 55
city: Zielona Gora
country: Poland
facility: Site 51
city: Moscow
country: Russian Federation
facility: Site 58
city: Moscow
country: Russian Federation
facility: Site 61
city: Moscow
country: Russian Federation
facility: Site 62
city: Moscow
country: Russian Federation
facility: Site 63
city: Moscow
country: Russian Federation
facility: Site 64
city: saint-Petersburg
country: Russian Federation
facility: Site 60
city: Samara
country: Russian Federation
facility: Site 59
city: Belville
country: South Africa
facility: Site 72
city: Belville
country: South Africa
facility: Site 75
city: Bloemfontein
country: South Africa
facility: Site 76
city: Durban
country: South Africa
facility: Site 98
city: Kempton Park
country: South Africa
facility: Site 73
city: Somerset West
country: South Africa
facility: Site 71
city: Worcester
country: South Africa
facility: Site 74
city: Barcelona
country: Spain
facility: Site 78
city: Barcelona
country: Spain
facility: Site 83
city: Madrid
country: Spain
facility: Site 79
city: Malaga
country: Spain
facility: Site 77
city: Santander
country: Spain
facility: Site 82
city: Valencia
country: Spain
facility: Site 80
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: