A Phase 2 interventional study of Istaroxime and Istaroxime in Heart Failure, sponsored by sigma-tau i.f.r. S.p.A.. Completed. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2008-02-15.
Sponsored by sigma-tau i.f.r. S.p.A. · Phase 2, Interventional, and Treatment
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.
Congestive heart failure is one of the most common cardiovascular conditions and it is presently reaching epidemic proportions. The prevalence of chronic heart failure has risen specifically as a result of the increased longevity and longer survival after myocardial infarction. In 2003, over one million hospitalization with a primary diagnosis of heart failure occurred in the United States of America, and a similar number has been reported in Europe, too. At present, approximately 5 million Americans are estimated to suffer of this syndrome and the number is expected to continue to increase with the increase and aging of the population. Despite advances in treatment, the mortality remains high in U.S.A. as in Europe, with nearly three hundred thousands patients dying of CHF as the primary or contributory cause each year.
The total number of hospital admissions approaches 3 million yearly when HF is listed as a primary or secondary diagnosis. Although these patients have a relatively low mortality during the hospitalization (less than 4%), the readmission rates within 60 days of discharge range from 20 to 30% and mortality within 60 days of discharge is 5 - 10%.
The primary aim of acute treatment of worsening CHF is to alleviate the symptoms of congestion and edema, improve the hemodynamic profile, and preserve renal function without causing myocardial injury. Improved hemodynamics usually results in relief of primary symptoms like dyspnea and edema and in a consequent improved sense of wellbeing and mental status. The improvement in hemodynamics may persist after the pharmacological interventions used in the acute phase are withdrawn.
The need in this setting is to decrease the filling pressures (RA pressure and PCWP), increase cardiac output, without increasing the heart rate and inducing/worsening atrial or ventricular arrhythmias. In addition, the agent should improve diastolic function, modulate the exaggerated neurohormonal responses to CHF and preserve/protect the viable but non contractile myocardium (e.g.: the hibernated myocardium). The agent should also facilitate the earlier start of life-saving therapies (e.g. beta - blockers).Pre-clinical data on Istaroxime show that this drug increases contractility without increasing heart rate and oxygen consumption; furthermore it is improving diastolic dysfunction and it not causing vasodilatation.
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's enrollment of 120 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →sigma-tau i.f.r. S.p.A. is the lead sponsor of 14 studies on the registry; none are open to participants now.
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Randomisation period inclusion criteria:
Exclusion Criteria:
Istaroxime dose of 0.5 microgram/kg body weight/minute of iv infusion for six ours
Drug: Istaroxime
Istaroxime dose of 1.0 microgram/kg body weight/minute of iv infusion for six ours
Drug: Istaroxime
Istaroxime dose of 1.5 microgram/kg body weight/minute of iv infusion for six ours
Drug: Istaroxime
Placebo iv infusion for six ours
Drug: Placebo
0.5 microgram/kg/min IV for 6 hours
Also known as: PST2744
1.0 microgram/kg/min IV for 6 hours
Also known as: PST2744
1.5 microgram/kg/min IV for 6 hours
Also known as: PST2744
Placebo
Also known as: placebo of PST2744
To determine the minimum effective dose of ISTAROXIME by comparing the hemodynamic effect of 3 different doses of the drug versus placebo. Efficacy will be measured as a change in PCWP from right heart catheterization.
Time frame: 6 hours drug infusion
safety, tolerability and efficacy on blood pressure, heart rate, cardiac index, stroke work index, right atrial pressure, systemic and pulmonary vascular resistances, Echocardiographic and Doppler parameters, neurohormonal parameters and renal function.
Time frame: 6 and 24 hours after start of infusion
No study locations are listed for this record.
This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.
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