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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

SLV320

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring congestive heart failure, adenosine receptor blocker, cardiac hemodynamic

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Site 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00160134

First Posted

September 8, 2005

Last Updated

January 29, 2009

Sponsor

Solvay Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00160134

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Solvay Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congestive Heart Failure

Keywords

congestive heart failure, adenosine receptor blocker, cardiac hemodynamic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

SLV320

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Director Solvay

Organizational Affiliation

Solvay Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Site 1

City

Bad Nauheim

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

19919976

Citation

Mitrovic V, Seferovic P, Dodic S, Krotin M, Neskovic A, Dickstein K, de Voogd H, Bocker C, Ziegler D, Godes M, Nakov R, Essers H, Verboom C, Hocher B. Cardio-renal effects of the A1 adenosine receptor antagonist SLV320 in patients with heart failure. Circ Heart Fail. 2009 Nov;2(6):523-31. doi: 10.1161/CIRCHEARTFAILURE.108.798389. Epub 2009 Sep 24.

Results Reference

derived

Congestive Heart Failure

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial