LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

a study on High Blood Pressure Pulmonary Hypertension Heart Failure Left Ventricular Ejection Fraction

Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

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).

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 (PH-HFpEF)

Details

This is a Phase 3, double-blind, randomized, placebo-controlled study of oral levosimendan in patients with PH-HFpEF. There will be a Screening Period of up to 30 days. Subjects will provide written informed consent prior to completing any study procedures. Upon meeting all eligibility criteria, patients will continue to the 12-week randomized, double-blind treatment phase. Approximately 230 subjects will be randomized in a 1:1 ratio to receive an oral dose of levosimendan or placebo

All randomized subjects will have the option to enter the 92-week OLE following the completion of all study events at Week 12.

Keywords

Pulmonary Hypertension, HFpEF, Pulmonary hypertension group 2, PH-HFpEF, Heart Failure, TNX-103

Eligibility

You can join if…

Open to people ages 18-85

  1. Men or women, greater than or equal to18 to 85 years of age.
  2. NYHA Class II or III or NYHA class IV symptoms.
  3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
  4. Qualifying Baseline RHC.
  5. Qualifying echocardiogram
  6. Qualifying 6-MWD
  7. A 48-hour ambulatory cardiac rhythm monitor during the Screening Period.
  8. Requirements related to child bearing potential, contraception, and egg/sperm donation

You CAN'T join if...

  1. A diagnosis of PH WHO Groups 1, 3, 4, or 5.
  2. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
  3. 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
  4. A diagnosis of pre-existing lung disease
  5. History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product.
  6. Major surgery within 60 days.
  7. Prior heart, lung, or heart-lung transplants or life expectancy of <12 months
  8. History of clinically significant other diseases that may limit or complicate participation in the study.

Locations

  • Tenax Investigational Site accepting new patients
    San Francisco California 94143 United States
  • Tenax Investigational Site accepting new patients
    La Jolla California 92037 United States
  • Tenax Investigational Site accepting new patients
    Los Angeles California 90048 United States
  • Tenax Investigational Site accepting new patients
    Irvine California 92868 United States
  • Tenax Investigational Site accepting new patients
    Los Angeles California 90033 United States
  • Tenax Investigational Site accepting new patients
    Sacramento California 95817 United States
  • Tenax Investigational Site accepting new patients
    Torrance California 90502 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tenax Therapeutics, Inc.
ID
NCT05983250
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 230 study participants
Last Updated
Contact us about this trial