Status:
COMPLETED
Levosimendan Efficacy Assessment by Cardiopulmonary Exercise Test (CPET)
Lead Sponsor:
Centro Cardiologico Monzino
Collaborating Sponsors:
Orion Corporation, Orion Pharma
Conditions:
Heart Failure
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief 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...
Detailed Description
Eligible patients should have chronic HF (Heart Failure -class NYHA III or IV) in stable clinical conditions. Inclusion criteria were: left ejection fraction (EF) at echocardiography ≤35%, age ≥18 yea...
Eligibility Criteria
Inclusion
- informed consent of the study signed
- severe heart failure in stable clinical condition (NYHA class III, peak VO2 \<12 ml / kg / min) in optimized medical therapy. The clinical stability is defined by the stability of the therapy, the weight and urine output for 3 days
Exclusion
- unstable patients from a clinical point of view, not in optimized therapy
- patients unable to perform a CPET (Cardiopulmonary Exercise Test) .
- are excluded from the protocol also patients with absolute contraindications to CPET (acute myocardial infarction, severe aortic stenosis, myocarditis or pericarditis, active, acute thromboembolism, sepsis,unstable angina, uncontrolled arrhythmia.
- age \< 18 years.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02261948
Start Date
September 1 2012
End Date
December 1 2014
Last Update
November 6 2015
Active Locations (1)
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1
Centro Cardiologico Monzino
Milan, MI, Italy, 20138