Phase 4
Completed N=42
Levosimendan Efficacy Assessment by Cardiopulmonary Exercise Test (CPET)
Source: ClinicalTrials.gov NCT02261948 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: Change in Peak VO2 (Oxygen Consumption ) — 1.21; 0.48 ml/kg/min
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Peak VO2 (Oxygen Consumption ) |
1.21; 0.48 | — |
| SECONDARY Changes in VE/VCO2 |
-5.34; -0.91 | — |
| SECONDARY Change in DLCO (Diffusion Lung CO) |
-0.96; 0.88 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02261948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.