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
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00568009 |
Recruitment Status :
Terminated
(additional enrolment criteria made patients' recruitment not feasible anymore)
First Posted : December 5, 2007
Last Update Posted : April 22, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Congestive Heart Failure | Drug: SLV320 |
Study Type : | Observational |
Estimated Enrollment : | 300 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 Start Date : | October 2007 |
Estimated Primary Completion Date : | November 2008 |
Estimated Study Completion Date : | November 2008 |

- Drug: SLV320
1, 2.5, 5, 10 and 20 mg twice daily and placebo group. Duration of treatment 84 days
- Cystatine C [ Time Frame: 3 months ]
- Sodium in urine [ Time Frame: 3 months ]
- Estimated glomerular filtration rate [ Time Frame: 3 months ]
- Clinical global impression [ Time Frame: 3 months ]
- Body weight [ Time Frame: 3 months ]
Biospecimen Retention: None Retained

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568009

Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
Responsible Party: | Kay-Christen Meyer, Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00568009 |
Other Study ID Numbers: |
S320.2.003 2007-000490-40 |
First Posted: | December 5, 2007 Key Record Dates |
Last Update Posted: | April 22, 2008 |
Last Verified: | April 2008 |
Congestive Heart Failure Impaired Renal Function |
Renal Insufficiency Heart Failure Heart Diseases |
Cardiovascular Diseases Kidney Diseases Urologic Diseases |