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

Solvay

Status and phase

Completed

Phase 2

Conditions

Congestive Heart Failure

Treatments

Drug: SLV320

Study type

Interventional

Funder types

Industry

Identifiers

NCT00160134

2004-000442-21

S320.2.002

Details and patient eligibility

About

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.

Sex

Male

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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