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Study to Evaluate Cardiac Hemodynamics and Safety of SLV320 in Subjects With Congestive Heart Failure

Sponsor
Solvay Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00160134
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

The study is a randomized, placebo controlled, multi-center, single dose study to evaluate cardiac hemodynamics and safety of iv SLV320 in 110 subjects with congestive heart failure requiring diuretic treatment. Each subject will receive one dose of SLV320 or placebo or furosemide. The study consists of three visits (or study days when in-subjects are included). Ambulatory subjects will be in hospital for two nights and one day.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Randomized, Placebo-Controlled, Double-Blind, Multi-Center, Parallel Group, Single Dose Study to Evaluate Cardiac Hemodynamics and Safety During Right Heart Catheterization of Three IV Doses of SLV320 in Subjects With Congestive Heart Failure Requiring Diuretic Treatment
Study Start Date :
Jan 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • history of chronic, symptomatic, mild to severe (NYHA Class II-IV) CHF for at least three months requiring treatment with diuretics and with documented systolic dysfunction

    • on stable doses of their individually optimized medication regimen for at least one week prior to enrollment

    Exclusion Criteria:

    • required hospitalization (for cardiovascular disease) or adjustment of background medications for CHF

    • orthostatic hypotension or symptomatic orthostasis

    • sitting systolic or diastolic blood pressure < 90 mmHg

    • 2nd or 3rd degree atrio-ventricular block or sick sinus syndrome

    • heart rate of < 50 or > 110 bpm on the ECG

    • transplanted heart

    • heart failure due to primary valvular disease (unless surgically corrected), obstructive cardiomyopathy, pericardial disease, cor pulmonale or congenital heart disease

    • hemodynamically significant left ventricular outflow tract obstruction

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 1 Bad Nauheim Germany

    Sponsors and Collaborators

    • Solvay Pharmaceuticals

    Investigators

    • Study Director: Global Clinical Director Solvay, Solvay Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00160134
    Other Study ID Numbers:
    • S320.2.002
    • 2004-000442-21
    First Posted:
    Sep 12, 2005
    Last Update Posted:
    Jan 30, 2009
    Last Verified:
    Jan 1, 2009
    Keywords provided by , ,
    congestive heart failure, adenosine receptor blocker, cardiac hemodynamic
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jan 30, 2009