๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-23

LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF (NCT05983250)

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)

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Tenax Therapeutics, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).

Who can join: Review the eligibility criteria below.

Location: Tenax Investigational Site โ€” Tucson, Arizona

Age range: 18 Years to 85 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (42 Sites)

Showing the first 25 of 42 sites.

  • Tenax Investigational Site โ€” Tucson, Arizona
  • Tenax Investigational Site โ€” La Jolla, California
  • Tenax Investigational Site โ€” Los Angeles, California
  • Tenax Investigational Site โ€” Los Angeles, California
  • Tenax Investigational Site โ€” Sacramento, California
  • Tenax Investigational Site โ€” San Francisco, California
  • Tenax Investigational Site โ€” Torrance, California
  • Tenax Investigational Site โ€” Jacksonville, Florida
  • Tenax Investigational Site โ€” Winter Haven, Florida
  • Tenax Investigational Site โ€” Atlanta, Georgia
  • Tenax Investigational Site โ€” Chicago, Illinois
  • Tenax Investigational Site โ€” Chicago, Illinois
  • Tenax Investigational Site โ€” Galesburg, Illinois
  • Tenax Investigational Site โ€” Indianapolis, Indiana
  • Tenax Investigational Site โ€” Indianapolis, Indiana
  • Tenax Investigational Site โ€” Louisville, Kentucky
  • Tenax Investigational Site โ€” Boston, Massachusetts
  • Tenax Investigational Site โ€” Minneapolis, Minnesota
  • Tenax Investigational Site โ€” Rochester, Minnesota
  • Tenax Investigational Site โ€” St Louis, Missouri
  • Tenax Investigational Site โ€” Omaha, Nebraska
  • Tenax Investigational Site โ€” New York, New York
  • Tenax Investigational Site โ€” New York, New York
  • Tenax Investigational Site โ€” Rochester, New York
  • Tenax Investigational Site โ€” Roslyn, New York

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—