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A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF)

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Trial Profile

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Dec 2025

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At a glance

  • Drugs Levosimendan (Primary)
  • Indications Heart failure; Pulmonary hypertension
  • Focus Registrational; Therapeutic Use
  • Acronyms LEVEL
  • Sponsors Tenax Therapeutics

Most Recent Events

  • 17 Dec 2025 Results presented in the Tenax Therapeutics Media Release.
  • 17 Dec 2025 According to Tenax Therapeutics media release, as per the Planned Review of Standard Deviation in the first 150 (two-thirds of patients) randomized, placebo-controlled patients- the prespecified Blinded Sample Size Re-estimation (BSSR) of LEVEL demonstrated the trial is powered at well over 90% to detect a 25 meter change in 6-minute walk distance (6MWD), the primary endpoint. The target enrollment remains unchanged. The assumptions based on data from the Phase 2 HELP trial are now confirmed.
  • 21 Aug 2025 Planned End Date changed from 1 May 2028 to 1 Oct 2028.

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