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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00160134

Enrollment

Unknown

Registered

2005-09-12

Start date

2005-01-31

Completion date

Unknown

Last updated

2009-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

Keywords

congestive heart failure, adenosine receptor blocker, cardiac hemodynamic

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.

Interventions

DRUGSLV320

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 85 Years

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026