Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF

Inclusion Criteria:

Criteria to enter Open-label, Lead-in Dose Phase:

Diagnosis of WHO Group 2 Pulmonary Hypertension (PH) with heart failure and preserved ejection fraction (HFpEF) confirmed at the time of the diagnosis of pulmonary hypertension.
Baseline Pulmonary Arterial Pressure (PAP) ≥35, PCWP ≥20, NYHA Class IIb/III, Left Ventricular Ejection Fraction (LVEF) ≥40%
Ability to walk at least 50 meters, but not more than 550 meters in a six-minute walk test.
Stable oxygen treatment (if applicable), and medications for heart failure, hypertension and respiratory condition

Criterion for Randomization to Double-blind Phase:

Response to Open-label, Lead-in Levosimendan: Patients who demonstrate a ≥4mmHg reduction in PCWP from baseline measured at bicycle exercise (25 watts) with no more than a 10% decrease from baseline in cardiac index

Exclusion Criteria:

Subject has primary diagnosis of PH other than Group 2 PH-HFpEF
Previous Percutaneous Coronary Intervention (PCI) or cardiac surgery (CABG) , unless they have a negative stress test in last 12 months)
Congenital heart disease
Clinically significant lung disease
Planned heart or lung surgery
Cardiac Index >4.0 L/min/m2
Concomitant administration of pulmonary vasodilator therapy or taken within 14 days
Dialysis or Glomerular Filtration Rate (GFR) <30 mL/min/1.73 m2
Liver dysfunction with Child Pugh Class B or C
Evidence of systemic infection
Weight > 150kg
Symptomatic systolic blood pressure (SBP) cannot be managed to ensure SBP >100 mmHg
Heart rate >= 100 bpm with study drug, symptomatic and persistent for at least 10 minutes
Hemoglobin < 80 g/L
Serum potassium < 3.0 mmol/L or > 5.5 mmol/L at baseline
Patients having severely compromised immune function
Pregnant, suspected to be pregnant, or breast-feeding