A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction
Status: Recruiting
Location: See all (88) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Men or women, ≥18 to 85 years of age
• NYHA Class II or III or ambulatory NYHA Class IV symptoms
• A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC)
• A qualifying baseline RHC
• A qualifying echocardiogram
• A qualifying 6-MWD
• A 48-hour ambulatory cardiac rhythm monitor during the Screening Period
• Requirements related to child bearing potential, contraception, and egg/sperm donation)
Locations
United States
Alabama
Tenax Investigational Site
NOT_YET_RECRUITING
Alexander City
Florida
Tenax Investigational Site
NOT_YET_RECRUITING
Tamarac
Illinois
Tenax Investigational Site
NOT_YET_RECRUITING
Mount Prospect
Tenax Investigational Site
NOT_YET_RECRUITING
Peoria
Louisiana
Tenax Investigational Site
NOT_YET_RECRUITING
New Orleans
Tenax Investigational Site
NOT_YET_RECRUITING
West Monroe
Michigan
Tenax Investigational Site
NOT_YET_RECRUITING
Ypsilanti
North Carolina
Tenax Investigational Site
NOT_YET_RECRUITING
Winston-salem
Nevada
Tenax Investigational Site
NOT_YET_RECRUITING
Reno
New York
Tenax Investigational Site
NOT_YET_RECRUITING
New York
Pennsylvania
Tenax Investigational Site
NOT_YET_RECRUITING
Allentown
Tenax Investigational Site
NOT_YET_RECRUITING
Wynnewood
Tennessee
Tenax Investigational Site
NOT_YET_RECRUITING
Nashville
Texas
Tenax Investigational Site
NOT_YET_RECRUITING
Austin
Tenax Investigational Site
RECRUITING
Houston
Virginia
Tenax Investigational Site
NOT_YET_RECRUITING
Norfolk
Wisconsin
Tenax Investigational Site
NOT_YET_RECRUITING
Marshfield
Other Locations
Argentina
Tenax Investigational Site
NOT_YET_RECRUITING
Buenos Aires
Tenax Investigational Site
NOT_YET_RECRUITING
Corrientes
Tenax Investigational Site
NOT_YET_RECRUITING
San Luis
Austria
Tenax Investigational Site
NOT_YET_RECRUITING
Braunau Am Inn
Tenax Investigational Site
NOT_YET_RECRUITING
Graz
Tenax Investigational Site
NOT_YET_RECRUITING
Klagenfurt
Tenax Investigational Site
NOT_YET_RECRUITING
Sankt Pölten
Tenax Investigational Site
NOT_YET_RECRUITING
Vienna
Brazil
Tenax Investigational Site
NOT_YET_RECRUITING
Belo Horizonte
Tenax Investigational Site
NOT_YET_RECRUITING
Curitiba
Tenax Investigational Site
NOT_YET_RECRUITING
Ribeirão Preto
Tenax Investigational Site
NOT_YET_RECRUITING
Salvador
Bulgaria
Tenax Investigational Site
NOT_YET_RECRUITING
Pleven
Tenax Investigational Site
NOT_YET_RECRUITING
Sofia
Tenax Investigational Site
NOT_YET_RECRUITING
Sofia
Tenax Investigational Site
NOT_YET_RECRUITING
Sofia
France
Tenax Investigational Site
NOT_YET_RECRUITING
Le Kremlin-bicêtre
Tenax Investigational Site
NOT_YET_RECRUITING
Montpellier
Tenax Investigational Site
NOT_YET_RECRUITING
Nantes
Tenax Investigational Site
NOT_YET_RECRUITING
Nice
Tenax Investigational Site
NOT_YET_RECRUITING
Pau
Germany
Tenax Investigational Site
NOT_YET_RECRUITING
Bad Bevensen
Tenax Investigational Site
NOT_YET_RECRUITING
Bad Nauheim
Tenax Investigational Site
NOT_YET_RECRUITING
Berlin
Tenax Investigational Site
NOT_YET_RECRUITING
Dresden
Tenax Investigational Site
NOT_YET_RECRUITING
Hamburg
Tenax Investigational Site
NOT_YET_RECRUITING
Jena
Hungary
Tenax Investigational Site
NOT_YET_RECRUITING
Budapest
Tenax Investigational Site
NOT_YET_RECRUITING
Budapest
Tenax Investigational Site
NOT_YET_RECRUITING
Debrecen
Tenax Investigational Site
NOT_YET_RECRUITING
Szeged
Italy
Tenax Investigational Site
NOT_YET_RECRUITING
Acquaviva Delle Fonti
Tenax Investigational Site
NOT_YET_RECRUITING
Messina
Tenax Investigational Site
NOT_YET_RECRUITING
Milan
Tenax Investigational Site
NOT_YET_RECRUITING
Milan
Tenax Investigational Site
NOT_YET_RECRUITING
Milan
Tenax Investigational Site
NOT_YET_RECRUITING
Pavia
Tenax Investigational Site
NOT_YET_RECRUITING
Pisa
Tenax Investigational Site
NOT_YET_RECRUITING
Roma
Tenax Investigational Site
NOT_YET_RECRUITING
Rozzano
Poland
Tenax Investigational Site
NOT_YET_RECRUITING
Poznan
Tenax Investigational Site
NOT_YET_RECRUITING
Wroclaw
Tenax Investigational Site
NOT_YET_RECRUITING
Wroclaw
Republic of Korea
Tenax Investigational Site
NOT_YET_RECRUITING
Cheongju-si
Tenax Investigational Site
NOT_YET_RECRUITING
Gwangju
Tenax Investigational Site
NOT_YET_RECRUITING
Incheon
Tenax Investigational Site
NOT_YET_RECRUITING
Seoul
Tenax Investigational Site
NOT_YET_RECRUITING
Seoul
Tenax Investigational Site
NOT_YET_RECRUITING
Wŏnju
Spain
Tenax Investigational Site
NOT_YET_RECRUITING
Barcelona
Tenax Investigational Site
NOT_YET_RECRUITING
Barcelona
Tenax Investigational Site
NOT_YET_RECRUITING
Barcelona
Tenax Investigational Site
NOT_YET_RECRUITING
Lugo
Tenax Investigational Site
NOT_YET_RECRUITING
Madrid
Tenax Investigational Site
NOT_YET_RECRUITING
Madrid
Tenax Investigational Site
NOT_YET_RECRUITING
Madrid
Tenax Investigational Site
NOT_YET_RECRUITING
Málaga
Tenax Investigational Site
NOT_YET_RECRUITING
Marbella
Tenax Investigational Site
NOT_YET_RECRUITING
Pamplona
Tenax Investigational Site
NOT_YET_RECRUITING
Salamanca
Tenax Investigational Site
NOT_YET_RECRUITING
Seville
Tenax Investigational Site
NOT_YET_RECRUITING
Toledo
Tenax Investigational Site
NOT_YET_RECRUITING
Valencia
Tenax Investigational Site
NOT_YET_RECRUITING
Valencia
Taiwan
Tenax Investigational Site
NOT_YET_RECRUITING
Kaohsiung City
Tenax Investigational Site
NOT_YET_RECRUITING
Kaohsiung City
Tenax Investigational Site
NOT_YET_RECRUITING
Taipei
Tenax Investigational Site
NOT_YET_RECRUITING
Taipei
Tenax Investigational Site
NOT_YET_RECRUITING
Taoyuan District
United Kingdom
Tenax Investigational Site
NOT_YET_RECRUITING
Cambridge
Tenax Investigational Site
NOT_YET_RECRUITING
Swindon
Contact Information
Primary
Akshata Ashokkumar
a.ashokkumar@tenaxthera.com
(919) 855-2118
Backup
Katelyn Jansson
k.jansson@tenaxthera.com
(919) 855-2119
Time Frame
Start Date: 2025-12
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 540
Treatments
Placebo_comparator: Placebo
Matching placebo (oral)
Active_comparator: TNX-103
Oral levosimendan
Related Therapeutic Areas
Sponsors
Leads: Tenax Therapeutics, Inc.