A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07288398Tipo: INTERVENTIONALInicio: 1 de dic de 2025Fin estimado: 30 de jun de 2029

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

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)

Criterios de exclusión

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

Intervenciones

drug

TNX-103

Oral levosimendan

drug

Placebo

Matching placebo (oral)

Ubicaciones

Tenax Investigational Site

Buenos Aires, Buenos Aires F.D., Argentina

NOT_YET_RECRUITING

Tenax Investigational Site

Corrientes, Corrientes Province, Argentina

NOT_YET_RECRUITING

Tenax Investigational Site

San Luis, San Luis Province, Argentina

NOT_YET_RECRUITING

Patrocinadores

PrincipalTenax Therapeutics, Inc.

Contactos

Akshata Ashokkumar

CONTACT

a.ashokkumar@tenaxthera.com (919) 855-2118

Katelyn Jansson

CONTACT

k.jansson@tenaxthera.com (919) 855-2119

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase 3, Double-Blind, Randomized, Placebo-Controlled S... | EligiMed