LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2

Study acronym: LEVEL-2
StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Enrollment closed, study ongoing
    • Study sites: 141 to 140
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 1 of 4 entries
  2. Trial sites expanded: 92 → 141 locationsv3
  3. Study sites: 91 to 92
    • Start date changed from estimate of Dec 2025 to Mar 3, 2026
    • Secondary endpoints revised (4)
    v2
  4. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07288398
Lead Sponsor Tenax Therapeutics, Inc.
Conditions
(from sponsor)		 Pulmonary Hypertension Associated With HFpEF
Related terms Heart Failure
Enrollment 540 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov