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Recruiting NCT07288398

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

Phase III Interventional Pulmonary Hypertension Associated With HFpEF

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TNX-103, Placebo.
Who it may be relevant to
Registry conditions: Pulmonary Hypertension Associated With HFpEF. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Austria, Brazil, Bulgaria +10
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • 6-Minute Walk Distance (6MWD) [Time frame: 26 weeks]
Secondary outcome measures (4)
  • KCCQ (Kansas City Cardiomyopathy Questionnaire) score is a standardized measure that ranges from 0 to 100, where a higher score indicates better health. [Time frame: 26 weeks]
  • Clinical Worsening Events [Time frame: 26 weeks]
  • Clinical Worsening Event [Time frame: 26 weeks]
  • NYHA (New York Heart Association) classification assesses and categorizes a patient's physical ability and symptoms into four classes, the lower the classification, the least impact on physical activity. [Time frame: 26 weeks]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • A diagnosis of PH WHO Groups 1, 3, 4, or 5
  • Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
  • Structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous) OR, planned valve intervention OR, the presence of significant valve disease
  • A diagnosis of pre-existing lung disease
  • History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product
  • Major surgery within 60 days
  • Prior heart, lung, or heart-lung transplants or life expectancy of <12 months
  • History of clinically significant other diseases that may limit or complicate participation in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 18 centers
  • Tenax Investigational Site — Alexander City
  • Tenax Investigational Site — Tamarac
  • Tenax Investigational Site — Mount Prospect
  • Tenax Investigational Site — Peoria
  • Tenax Investigational Site — New Orleans
  • Tenax Investigational Site — West Monroe
  • Tenax Investigational Site — Ypsilanti
  • Tenax Investigational Site — Reno
  • … and 10 more centers
Spain · 15 centers
  • Tenax Investigational Site — Barcelona
  • Tenax Investigational Site — Barcelona
  • Tenax Investigational Site — Barcelona
  • Tenax Investigational Site — Lugo
  • Tenax Investigational Site — Madrid
  • Tenax Investigational Site — Madrid
  • Tenax Investigational Site — Madrid
  • Tenax Investigational Site — Marbella
  • … and 7 more centers
Italy · 9 centers
  • Tenax Investigational Site — Acquaviva delle Fonti
  • Tenax Investigational Site — Messina
  • Tenax Investigational Site — Milan
  • Tenax Investigational Site — Milan
  • Tenax Investigational Site — Milan
  • Tenax Investigational Site — Pavia
  • Tenax Investigational Site — Pisa
  • Tenax Investigational Site — Roma
  • … and 1 more center
Germany · 6 centers
  • Tenax Investigational Site — Bad Bevensen
  • Tenax Investigational Site — Bad Nauheim
  • Tenax Investigational Site — Berlin
  • Tenax Investigational Site — Dresden
  • Tenax Investigational Site — Hamburg
  • Tenax Investigational Site — Jena
South Korea · 6 centers
  • Tenax Investigational Site — Cheongju-si
  • Tenax Investigational Site — Gwangju
  • Tenax Investigational Site — Incheon
  • Tenax Investigational Site — Seoul
  • Tenax Investigational Site — Seoul
  • Tenax Investigational Site — Wŏnju
Austria · 5 centers
  • Tenax Investigational Site — Braunau am Inn
  • Tenax Investigational Site — Graz
  • Tenax Investigational Site — Klagenfurt
  • Tenax Investigational Site — Sankt Pölten
  • Tenax Investigational Site — Vienna
France · 5 centers
  • Tenax Investigational Site — Le Kremlin-Bicêtre
  • Tenax Investigational Site — Montpellier
  • Tenax Investigational Site — Nantes
  • Tenax Investigational Site — Nice
  • Tenax Investigational Site — Pau
Taiwan · 5 centers

Center list to be confirmed — check the primary protocol.

Brazil · 4 centers
  • Tenax Investigational Site — Salvador
  • Tenax Investigational Site — Belo Horizonte
  • Tenax Investigational Site — Curitiba
  • Tenax Investigational Site — Ribeirão Preto
Bulgaria · 4 centers
  • Tenax Investigational Site — Pleven
  • Tenax Investigational Site — Sofia
  • Tenax Investigational Site — Sofia
  • Tenax Investigational Site — Sofia
Hungary · 4 centers
  • Tenax Investigational Site — Budapest
  • Tenax Investigational Site — Budapest
  • Tenax Investigational Site — Debrecen
  • Tenax Investigational Site — Szeged
Argentina · 3 centers
  • Tenax Investigational Site — Buenos Aires
  • Tenax Investigational Site — Corrientes
  • Tenax Investigational Site — San Luis
Czechia · 3 centers
  • Tenax Investigational Site — Ostrava
  • Tenax Investigational Site — Prague
  • Tenax Investigational Site — Prague
Poland · 3 centers
  • Tenax Investigational Site — Poznan
  • Tenax Investigational Site — Wroclaw
  • Tenax Investigational Site — Wroclaw
United Kingdom · 2 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07288398 · TNX-103-07 · 2025-522475-28-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗