Status:
COMPLETED
Study to Evaluate Cardiac Hemodynamics and Safety of SLV320 in Subjects With Congestive Heart Failure
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Congestive Heart Failure
Eligibility:
MALE
18-85 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00160134
Start Date
January 1 2005
Last Update
January 30 2009
Active Locations (1)
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1
Site 1
Bad Nauheim, Germany