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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:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00160134
First received: September 8, 2005
Last updated: January 29, 2009
Last verified: January 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

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 by Solvay Pharmaceuticals

Additional 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
Study First Received: September 8, 2005
Last Updated: January 29, 2009
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 May 16, 2013