clinical trial · NCT07288398
LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
Pulmonary Hypertension Associated With HFpEFTNX-103Placebo
brief summary
The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.
started
Mar 3, 2026
primary completion
Jun 30, 2028
completion
Jun 30, 2029
last updated
Mar 16, 2026
detailed description
Approximately 540 participants will be randomized in a 2:1 ratio to receive an oral dose of levosimendan or placebo. Participants will be eligible for an open label extension (OLE) of 52-weeks.
official title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol