Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF (NCT03541603) | Clinical Trial Compass
CompletedPhase 2
Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF
United States44 participantsStarted 2018-11-14
Plain-language summary
Phase 2 study to evaluate the efficacy and safety of intermittent levosimendan compared with placebo in hemodynamic improvement with exercise in PH-HFpEF subjects
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Change From Baseline Pulmonary Capillary Wedge Pressure (PCWP) With Bicycle Exercise