Tenax Phase 3: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

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

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Overview
Principal Investigator: Ioana Preston, MD

The primary objective is to evaluate the efficacy of levosimendan TNX-103 compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance from Day 1 to Week 12. This is a multicenter, parallel, double-blind study in subjects with PH-HFpEF and will be screened for a 1:1 ratio to receive an oral dose of 2 mg/day levosimendan or placebo for Weeks 1 to 4 and 3 mg/day for Weeks 5 to 12.

Study details
Inclusion Criteria
  • 1. Men or women, 18 to 85 years of age.
  • 2. NYHA Class II or III or ambulatory NYHA class IV symptoms.
  • 3. A qualifying Baseline RHC performed within 120 days of Day 1. The RHC can be a
    historical RHC done prior to study consent.
Exclusion Criteria
  • 1. A diagnosis of PH WHO Groups 1, 3, 4, or 5.
  • 2. Walking activity that is limited by anything other than shortness of breath or fatigue
    attributed to PH-HFpEF. This includes:
    a. Arthritis and rheumatologic disorders.
    b. Muscular disorders.
    c. Neurologic disorders.
    d. Peripheral vascular disease.
    e. Generalized weakness.
  • 3. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive
    cardiomyopathy, constrictive pericarditis, cardiac amylo
Study Requirements

There will be 5 onsite visits with a phone call in stage 1 and then 2 follow-up phone calls also in stage 1. Stage 1 lasts 12 weeks. During the study, the total amount of blood taken will be approximately 227 mL (46 teaspoons). A total of no more than 16.5 mL (3 teaspoons) of blood will be required for all the screening tests. No more than 16.5 mL (3 teaspoons) of blood will be collected on any study visit day after screening. There are no MRIs, CT scans or x-rays. If subjects want to continue levosimendan, they may continue in extension part of trial: Stage 2 for 92 weeks.