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

Congestive Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00568009
• Other study ID #: S320.2.003
• Secondary ID: 2007-000490-40
• Status: Terminated
• Phase: N/A
• First received: December 4, 2007
• Last updated: April 18, 2008
• Start date: October 2007
• Est. completion date: November 2008

Study information

• Verified date: April 2008
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Renal Insufficiency

Intervention

Drug:
• SLV320
1, 2.5, 5, 10 and 20 mg twice daily and placebo group. Duration of treatment 84 days

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals	Quintiles, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Czech Republic,  Former Serbia and Montenegro,  Germany,  Poland,  Russian Federation,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cystatine C		3 months	No
Secondary	Sodium in urine		3 months	No
Secondary	Estimated glomerular filtration rate		3 months	No
Secondary	Clinical global impression		3 months	No
Secondary	Body weight		3 months	No