At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 120 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Istaroxime 0.5 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Clinical Study of the Safety and Efficacy of Istaroxime in Treatment of Acute Decompensated Heart Failure - A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Clinical Study
In Brief
A Phase 2 clinical trial evaluating Placebo and Istaroxime for Acute Decompensated Heart Failure. Completed, enrolled 120 participants across 11 sites in 2 countries.
Detailed Summary
To assess the safety, tolerability and efficacy of two different doses of istaroxime, a new agent with lusitropic and inotropic activities that improves the cardiac contraction-relaxation cycle. The 2 doses of istaroxime (0.5 and 1.0 µg/kg/min) will be infused via i. v. for 24 hours in comparison with placebo, in treatment of Chinese and Italian patients with Acute Decompensated Heart Failure.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Decompensated Heart Failure
CountriesChina, Italy
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartDec 2015
Primary CompletionAug 2018
Study CompletionFeb 2019
TodayJul 2026
First PostedDec 1, 2015
Enrollment StartDec 1, 2015
Primary CompletionAug 14, 2018
Study CompletionFeb 6, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.6 years ago
Interventions
Placebodrug
IV of matching saline solution
Istaroximedrug
IV infusion of 0.5 µg/kg/min or 1.0 µg/kg/min istaroxime