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TerminatedNCT00568009Updated Apr 22, 2008

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 in Congestive Heart Failure, sponsored by Solvay Pharmaceuticals. Terminated at 72 sites in 10 countries. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-04-22.

Sponsored by Solvay Pharmaceuticals (part of Abbott) · Observational

Why this study was terminated
additional enrolment criteria made patients' recruitment not feasible anymore
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Congestive Heart Failure

Keywords

  • Congestive Heart Failure
  • Impaired Renal Function
03

In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's planned enrollment of 300 is above the median of 200 across 1,719 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Solvay Pharmaceuticals is the lead sponsor of 86 studies on the registry; none are open to participants now.

First submitted before Solvay Pharmaceuticals became part of Abbott.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Study population

Congestive Heart Failure, Impaired Renal Function

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Biospecimen retention
None retained

Interventions

  • DrugSLV320

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

06

What researchers measure

Primary outcomes

  1. Cystatine C

    Time frame: 3 months

Secondary outcomes

  1. Sodium in urine

    Time frame: 3 months

  2. Estimated glomerular filtration rate

    Time frame: 3 months

  3. Clinical global impression

    Time frame: 3 months

  4. Body weight

    Time frame: 3 months

07

Study locations

72 sites
  • Site 96
    Whittier, California, United States
  • Site 95
    Largo, Florida, United States
  • Site 90
    Miami, Florida, United States
  • Site 88
    Atlanta, Georgia, United States
  • Site 92
    Covington, Georgia, United States
  • Site 106
    Melrose Park, Illinois, United States
  • Site 87
    Hagerstown, Maryland, United States
  • Site 94
    Springfield Gardens, New York, United States
  • Site 89
    Dallas, Texas, United States
  • Site 97
    San Antonio, Texas, United States
  • Site 11
    Bahía Blanca, Argentina
  • Site 2
    Bahía Blanca, Argentina
  • Site 101
    Capital Federal, Argentina
  • Site 6
    Coronel Suárez, 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, Argentina
  • Site 14
    Antwerp, Belgium
  • Site 15
    Ghent, Belgium
  • Site 12
    Huy, Belgium
  • Site 22
    Brno, Czechia
  • Site 16
    Jindřichův Hradec, Czechia
  • Site 19
    Kroměříž, Czechia
  • Site 20
    Prague, Czechia
  • Site 21
    Prague, Czechia
  • Site 17
    Semily, Czechia
  • Site 18
    Slaný, Czechia
  • Site 23
    Teplice, Czechia
  • Site 24
    Bad Nauheim, Germany
  • Site 28
    Berlin, Germany
  • Site 26
    Dortmund, Germany
  • Site 50
    Bydgoszcz, Poland
  • Site 47
    Lublin, Poland
  • Site 49
    Płock, Poland
  • Site 57
    Skierniewice, Poland
  • Site 54
    Torun, Poland
  • Site 48
    Warsaw, Poland
  • Site 52
    Warsaw, Poland
  • Site 53
    Warsaw, Poland
  • Site 56
    Warsaw, Poland
  • Site 55
    Wroclaw, Poland
  • Site 51
    Zielona Góra, Poland
  • Site 58
    Moscow, Russia
  • Site 61
    Moscow, Russia
  • Site 62
    Moscow, Russia
  • Site 63
    Moscow, Russia
  • Site 64
    Moscow, Russia
  • Site 60
    Saint Petersburg, Russia
  • Site 59
    Samara, Russia
  • Site 65
    Belgrade, Serbia and Montenegro
  • Site 66
    Belgrade, Serbia and Montenegro
  • Site 69
    Belgrade, Serbia and Montenegro
  • Site 68
    Niska Banja, Serbia and Montenegro
  • Site 67
    Sremska Kamenica, Serbia and Montenegro
  • Site 70
    Zemun, Serbia and Montenegro
  • 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, South Africa
  • Site 78
    Barcelona, Spain
  • Site 83
    Barcelona, Spain
  • Site 79
    Madrid, Spain
  • Site 77
    Málaga, Spain
  • Site 82
    Santander, Spain
  • Site 80
    Valencia, Spain
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2007, a primary completion of Nov 2008 and a completion of Nov 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 4, 2007
First posted
Dec 5, 2007
Start
Oct 2007
Primary completionEst.
Nov 2008
CompletionEst.
Nov 2008
Last update
Apr 22, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00568009
Collaborators
Quintiles, Inc.
First posted
Dec 5, 2007
Start date
Oct 2007
Primary completion
Nov 2008 (estimated)
Completion
Nov 2008 (estimated)
Last update
Apr 22, 2008

Study contacts

Global Clinical Director Solvay
study director · Solvay Pharmaceuticals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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