Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT03541603
Eligibility Criteria:
Inclusion Criteria:
Criteria to enter Open-label, Lead-in Dose Phase:
* Diagnosis of World Health Organization (WHO) Group 2 Pulmonary Hypertension (PH) with Heart Failure with Preserved Ejection Fraction (HFpEF) confirmed at the time of the diagnosis of pulmonary hypertension.
* Baseline Pulmonary Arterial Pressure (PAP) ≥35, Pulmonary Capillary Wedge Pressure (PCWP) ≥20, New York Heart Association (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 a 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 the 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 the 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03541603
Study Brief:
Protocol Section:
NCT03541603