Mechanism Of ActionDual mechanism of levosimendan, including reduction of splanchnic venous constriction that lowers venous and pulmonary pressures, offers a clear physiological rationale for potential efficacy in PH-HFpEF.
Patient-reported OutcomesAnecdotal improvements in the open-label extension indicate oral levosimendan may reduce symptom burden for patients with PH-HFpEF and improve functional capacity.
Trial Statistical PowerLEVEL Phase III trial remains greater than 90% powered to detect a clinically meaningful change in six-minute walk distance, supporting confidence in the study's ability to demonstrate benefit.