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

This study has been completed.

First Received: September 8, 2005 Last Updated: January 29, 2009 History of Changes

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00160134

Purpose

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	Intervention	Phase
Congestive Heart Failure	Drug: SLV320	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date:

January 2005

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160134

Locations

Germany
Site 1
Bad Nauheim, Germany

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	S320.2.002, 2004-000442-21
Study First Received:	September 8, 2005
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00160134 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Norway: Norwegian Medicines Agency

Keywords provided by Solvay Pharmaceuticals:

congestive heart failure, adenosine receptor blocker, cardiac hemodynamic

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 27, 2009