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)

A
Ankit Desai

Primary Investigator

Enrolling By Invitation
18 years - 85 years
All
Phase 3
2 participants needed
1 Location

Brief description of study

What is the purpose of this study?

The study will evaluate the efficacy and safety of chronic oral levosimendan compared with placebo in PH-HFpEF subjects. This subject population represents a large and growing group with no established therapies to treat their PVD and RV dysfunction. Levosimendan and its prolonged active metabolite, OR-1896, have been shown to have favorable hemodynamic effects in subjects with PH and right HF. PH-HFpEF. 

 

THIS STUDY IS ENROLLING BY INVITATION ONLY 

Detailed description of study

What will happen during the study?

  • There will be a Screening Period of up to 30 days.
  • Subjects will provide written informed consent prior to completing any study procedures. Upong all eligibility criteria, patients will continue to the 12-weekdomized, double-blind treatment phase.
  • Approximately 152 subjects will be randomized in a 1:1 ratio to receive an oral dose of levosimendan or placebo 2 mg/day for Weeks 1 to 4 and 3 mg/day for Weeks 5 to 12.
  • Subjects will return to the clinical site at Weeks 4, 8, and 12.
  • All randomized subjects will have the option to enter the 92-week OLE following the completion of all study events at Week 12.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pulmonary Hypertension, PH-HFpEF
  • Age: 18 years - 85 years
  • Gender: All

Inclusion Criteria:

  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

Exclusion Criteria:

  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.

Updated on 30 Apr 2025. Study ID: KIC-TENAX-DESAI-LEVEL, 23623
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only