Phase 4 N=42 Randomized Triple-blind Treatment

Levosimendan Efficacy Assessment by Cardiopulmonary Exercise Test (CPET)

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT02261948 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: Change in Peak VO2 (Oxygen Consumption ) — 1.21; 0.48 ml/kg/min

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Levosimendan (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Centro Cardiologico Monzino
Primary completion: Sep 2014

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	—

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.

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.

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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.