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

Congestive Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160134
• Other study ID #: S320.2.002
• Secondary ID: 2004-000442-21
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: January 29, 2009
• Start date: January 2005

Study information

• Verified date: January 2009
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSerbia and Montenegro: Agency for Drugs and Medicinal DevicesNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• SLV320

Locations

Country	Name	City	State
Germany	Site 1	Bad Nauheim

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

Germany,