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

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

January 29, 2009

Start Date ^ICMJE

January 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00160134 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Congestive Heart Failure

Intervention ^ICMJE

Drug: SLV320

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00160134

Responsible Party

Study ID Numbers ^ICMJE

S320.2.002, 2004-000442-21

Study Sponsor ^ICMJE

Solvay Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

Information Provided By

Solvay Pharmaceuticals

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP