Levosimendan in PH-HFpEF

What is the Purpose of this Study?

This study focuses on people who have pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF), also known as diastolic heart failure or diastolic dysfunction. This is a type of heart failure in which the heart is stiffer and does not relax and fill appropriately, which can lead to increased blood pressure in the lungs. Patients who have this condition may feel short of breath or have difficulty doing physical activity. The purpose of the study is to evaluate an experimental drug called levosimendan in patients who have PH-HFpEF. The study has 2 stages. In the first stage, researchers will assess whether levosimendan, compared to placebo (inactive substance), improves the distance participants with PH-HFpEF can walk in 6 minutes. Participants will be randomly assigned to receive either levosimendan or placebo. In the second stage, all participants will receive levosimendan, and its effects and safety will be evaluated for a longer period of time. Stage 2 is optional. Levosimendan is approved for use as an infusion (intravenous injection) to treat hospitalized patients with breathing difficulties associated with a type of serious heart failure; however, it is considered experimental in this study because it has not been approved by the U.S. Food and Drug Administration (FDA) to treat PH-HFpEF or approved to be taken by mouth.


Eligibility

  • 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.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

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

Study Details
Disease Type/Condition

Other

Principal Investigator

Matusov, Yuri

Age Group

Adult

Phase

III

IRB Number

STUDY00003235

ClinicalTrials.gov ID

NCT05983250

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Matusov, Yuri

Age Group

Adult

Phase

III

IRB Number

TNX-103-06

ClinicalTrials.gov ID

NCT05983250

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org