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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00160134
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 30, 2009
Information provided by:
Solvay Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: SLV320 Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00160134

Site 1
Bad Nauheim, Germany
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00160134     History of Changes
Other Study ID Numbers: S320.2.002
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 30, 2009
Last Verified: January 2009

Keywords provided by Solvay Pharmaceuticals:
congestive heart failure, adenosine receptor blocker, cardiac hemodynamic

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases