CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 42 enrolled
Drug / intervention
Levosimendan +1 moredrug
Likely dose
Levosimendan 12 mcgfrom 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.

Search/NCT02261948
NCT02261948Phase 4Completed
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Levosimendan Efficacy Assessment by Cardiopulmonary Exercise Test (CPET)

Centro Cardiologico Monzino·interventional·Posted Oct 10, 2014·Updated Nov 6, 2015

In Brief

A Phase 4 clinical trial evaluating Levosimendan and Placebo for Heart Failure. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The present study was conceived to evaluate the effects of levosimendan on cardiopulmonary exercise test (CPET) and DLCO ( Diffusion capacity of Lung for carbon monoxide) in patients with severe heart failure in stable clinical conditions (NYHA - New York Heart Association - class III, with a peak VO2 (Oxygen consumption ) \< 12 ml/min/kg) on top of optimized standard therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesItaly
CollaboratorsOrion Corporation, Orion Pharma

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2014
Enrollment StartSep 1, 2012
Primary CompletionSep 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 11.7 years ago

Interventions

Levosimendandrug

Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min.

Placebodrug

Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min.