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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00160134
First Posted: September 12, 2005
Last Update Posted: January 30, 2009
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.
Information provided by:
Solvay Pharmaceuticals
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: January 2005
  Eligibility

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, Senior)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): NCT00160134


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00160134     History of Changes
Other Study ID Numbers: S320.2.002
2004-000442-21
First Submitted: September 8, 2005
First Posted: September 12, 2005
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