Congestive Heart FailureNCT00568009
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
An observational study of Congestive Heart Failure, run by Solvay Pharmaceuticals at 72 sites in 10 countries.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- SLV320
- How many people
- 300 participants
- Where
- 72 sitesin 10 countries
- Study dates
- Oct 2007to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Congestive Heart Failure, Impaired Renal Function
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
72 sites in 10 countries.
72 sites in 10 countries
Argentina11 sites
Site 11
Bahía Blanca
Site 2
Bahía Blanca
Site 101
Capital Federal
Site 6
Coronel Suárez
Site 1
Corrientes
Site 5
La Plata
Site 104
Mar del Plata
Site 102
Salta
Site 105
San Luis
Site 4
San Martin
Site 8
Santa Fe
Poland11 sites
Site 50
Bydgoszcz
Site 47
Lublin
Site 49
Płock
Site 57
Skierniewice
Site 54
Torun
Site 48
Warsaw
Site 52
Warsaw
Site 53
Warsaw
Site 56
Warsaw
Site 55
Wroclaw
Site 51
Zielona Góra
United States10 sites
Site 88
Atlanta, Georgia
Site 92
Covington, Georgia
Site 89
Dallas, Texas
Site 87
Hagerstown, Maryland
Site 95
Largo, Florida
Site 106
Melrose Park, Illinois
Site 90
Miami, Florida
Site 97
San Antonio, Texas
Site 94
Springfield Gardens, New York
Site 96
Whittier, California
Czechia8 sites
Site 22
Brno
Site 16
Jindřichův Hradec
Site 19
Kroměříž
Site 20
Prague
Site 21
Prague
Site 17
Semily
Site 18
Slaný
Site 23
Teplice
Russia7 sites
Site 58
Moscow
Site 61
Moscow
Site 62
Moscow
Site 63
Moscow
Site 64
Moscow
Site 60
Saint Petersburg
Site 59
Samara
South Africa7 sites
Site 72
Belville
Site 75
Belville
Site 76
Bloemfontein
Site 98
Durban
Site 73
Kempton Park
Site 71
Somerset West
Site 74
Worcester
Serbia and Montenegro6 sites
Site 65
Belgrade
Site 66
Belgrade
Site 69
Belgrade
Site 68
Niska Banja
Site 67
Sremska Kamenica
Site 70
Zemun
Spain6 sites
Site 78
Barcelona
Site 83
Barcelona
Site 79
Madrid
Site 77
Málaga
Site 82
Santander
Site 80
Valencia
About this study
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
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.
- Conditions
- Congestive Heart Failure
- Being tested
- SLV320
- Keywords
- Congestive Heart Failure, Impaired Renal Function
- Medical subject headings
- Heart Failure, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLV320Drug
1, 2.5, 5, 10 and 20 mg twice daily and placebo group. Duration of treatment 84 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Cystatine C
Measured: 3 months
Secondary outcomes (4)
Sodium in urine
Measured: 3 months
Estimated glomerular filtration rate
Measured: 3 months
Clinical global impression
Measured: 3 months
Body weight
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionNov 2008 (estimated)
- Study completionNov 2008 (estimated)
Why it stopped: additional enrolment criteria made patients' recruitment not feasible anymore
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568009
- Sponsor's protocol ID
- S320.2.003
- Other IDs
- 2007-000490-40
- Status last verified
- Apr 2008
- First submitted
- 4 Dec 2007
- Last updated
- 22 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00568009
- Acronym / sponsor ID
- S320.2.003
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive Heart Failure, Impaired Renal Function
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: additional enrolment criteria made patients' recruitment not feasible anymore
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Oct 2007
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 5 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Congestive Heart Failure, Impaired Renal Function
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLV3201, 2.5, 5, 10 and 20 mg twice daily and placebo group. Duration of treatment 84 days | Drug | – |
Primary outcome
Cystatine C
Time frame: 3 months
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: additional enrolment criteria made patients' recruitment not feasible anymore). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
72 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Solvay Pharmaceuticals at 72 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in Argentina, Poland, United States, Czechia, Russia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: additional enrolment criteria made patients' recruitment not feasible anymore). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cystatine C (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2008.