A Phase II Trial to Assess Hemodynamic Effects of Istaroxime in Pts With Worsening HF and Reduced LV Systolic Function

Summary

The purpose of this study is to determine the minimum effective dose of Istaroxime, in patients requiring hospitalization for deterioration of chronic heart failure and left ventricular systolic dysfunction. This goal will be reached by comparing the hemodynamic effect of three different doses of the drug versus placebo. Efficacy will be measured as a change in Pulmonary Capillary Wedge Pressure from pre-infusion to the last assessment at six hours intravenous infusion.Secondary objectives will be to evaluate safety, tolerability and efficacy on other main hemodynamic parameters, echocardiographic and echo-doppler measurements, plus preliminary pharmacokinetics of the drug.

Conditions

• Heart Failure

Interventions

DRUG

Istaroxime

0.5 microgram/kg/min IV for 6 hours

DRUG

Istaroxime

1.0 microgram/kg/min IV for 6 hours

DRUG

Istaroxime

1.5 microgram/kg/min IV for 6 hours

DRUG

Placebo

Placebo

Sponsors & Collaborators

• MDS Pharma Services

  collaborator INDUSTRY

• sigma-tau i.f.r. S.p.A.

  lead INDUSTRY

Principal Investigators

• Mihai Gheorghiade, MD FACC · Northwestern University Feinberg School of Medicine - Chicago

• Witold Ruzyllo, MD · National Institute of Cardiology, Department of Coronary Artery Disease - Warsaw - POLAND

• Cezar Macarie, MD · Insitutul de Boli Cardiovasculare C.C. Iliescu Bucuresti, Bucharest - ROMANIA

• Dimitrios Th Kremastinos, MD · Second Cardiology Department, Athens University Medical School, University Hospital Attikon, Athens - GREECE

• Serban I Bubenek-Turconi, MD · First Anaesth. & Intensive Care Dept., CC Iliescu Heart Disease Institute, Bucharest - ROMANIA

• Maria Dorobantu, MD · Emergency Hospital "Loreasca", Bucharest - ROMANIA

• Jerzy Korewicki, MD · National Institute of Cardiology, Warsaw, Poland

• Jaroslaw Drodz, MD · Hospital bieganskieko , Dept of Cardiology, Lodz - POLAND

• Piotr Ponikowski, MD · Iv Military Hospital, Wroclaw, POLAND

• John N Nanas, MD PhD · Alexandra University Hospital, Athens - GREECE

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-08-31

Primary Completion

2007-07-31

Completion

2007-08-31