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Levosimendan Efficacy Assessment by Cardiopulmonary Exercise Test (CPET)

NCT02261948 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2015-11-06

Study results available
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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.

Conditions

Interventions

DRUG

Levosimendan

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    collaborator INDUSTRY

  • Centro Cardiologico Monzino

    lead OTHER

Principal Investigators

  • Piergiuseppe Agostoni, MD, PhD · Centro Cardiologico Monzino,IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02261948 on ClinicalTrials.gov