Study to Evaluate Cardiac Hemodynamics and Safety of SLV320 in Subjects With Congestive Heart Failure
Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congestive Heart Failure
Intervention: SLV320 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Site 1, Bad Nauheim, Germany
Additional Information
Starting date: January 2005
Last updated: July 13, 2007
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