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

Part of paid clinical trials in Alexander City, Alabama.

Sponsor
Tenax Therapeutics, Inc.
Study ID
NCT07288398
Phase
PHASE3
Status
Recruiting
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Conditions

  • Pulmonary Hypertension Associated With HFpEF

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • TNX-103 — DRUG
    Oral levosimendan
  • Placebo — DRUG
    Matching placebo (oral)

Study Details

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.

Key Dates

First listed
Dec 17, 2025
Start date
Mar 3, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
540 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Matching placebo (oral)
  • Active Comparator: TNX-103
    Oral levosimendan

Primary Outcome Measure

6-Minute Walk Distance (6MWD) [ Time Frame: 26 weeks ]

Central Contacts

Locations (46)

FacilityCityStateZIPSite coordinators
Tenax Investigational SiteAlexander CityAlabama35010-
Tenax Investigational SiteTucsonArizona85724-
Tenax Investigational SiteSacramentoCalifornia95816-
Tenax Investigational SiteSan FranciscoCalifornia94143-
Tenax Investigational SiteStanfordCalifornia94305-5208-
Tenax Investigational SiteTorranceCalifornia90502-
Tenax Investigational SiteAthensGeorgia30606-
Tenax Investigational SiteAtlantaGeorgia30322-
Tenax Investigational SiteChicagoIllinois60611-4494-
Tenax Investigational SiteChicagoIllinois60637-
Tenax Investigational SiteMount ProspectIllinois60056-
Tenax Investigational SitePeoriaIllinois61636-
Tenax Investigational SiteIndianapolisIndiana46260-
Tenax Investigational SiteNew OrleansLouisiana70115-6969-
Tenax Investigational SiteWest MonroeLouisiana71291-
Tenax Investigational SiteBostonMassachusetts02114-2621-
Tenax Investigational SiteAnn ArborMichigan48109-
Tenax Investigational SiteYpsilantiMichigan48197-
Tenax Investigational SiteMinneapolisMinnesota55455-
Tenax Investigational SiteRochesterMinnesota55905-
Tenax Investigational SiteKansas CityMissouri64111-
Tenax Investigational SiteSt LouisMissouri63136-
Tenax Investigational SiteOmahaNebraska68198-
Tenax Investigational SiteRenoNevada89502-
Tenax Investigational SiteNew YorkNew York10021-
Tenax Investigational SiteNew YorkNew York10032-
Tenax Investigational SiteRochesterNew York14617-
Tenax Investigational SiteDurhamNorth Carolina27710-
Tenax Investigational SiteWinston-SalemNorth Carolina27101-
Tenax Investigational SiteClevelandOhio44195-0001-
Tenax Investigational SiteColumbusOhio43210-
Tenax Investigational SiteAllentownPennsylvania18105-
Tenax Investigational SitePittsburghPennsylvania15212-
Tenax Investigational SiteWynnewoodPennsylvania19096-3450-
Tenax Investigational SiteCharlestonSouth Carolina29425-
Tenax Investigational SiteNashvilleTennessee37205-
Tenax Investigational SiteAustinTexas78705-
Tenax Investigational SiteDallasTexas75390-
Tenax Investigational SiteEl PasoTexas79905-2707-
Tenax Investigational SiteHoustonTexas77002-
Tenax Investigational SiteHoustonTexas77030-2342-
Tenax Investigational SiteCharlottesvilleVirginia22908-
Tenax Investigational SiteNorfolkVirginia23507-1904-
Tenax Investigational SiteSeattleWashington98122-
Tenax Investigational SiteMadisonWisconsin53706-
Tenax Investigational SiteMarshfieldWisconsin54449-

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