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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Congestive Heart Failure

Keywords

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congestive heart failure, adenosine receptor blocker, cardiac hemodynamic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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SLV320

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 1

Bad Nauheim, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED

PMID: 19919976 (View on PubMed)

Other Identifiers

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2004-000442-21

Identifier Type: -

Identifier Source: secondary_id

S320.2.002