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)
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Tenax Therapeutics, Inc.
- Enrollment
- 230
- Locations
- 42
- Primary Endpoint
- Change in Six-minute walk distance
Study Overview
Brief 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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The blind is maintained by the use of a matching placebo.
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men or women, greater than or equal to18 to 85 years of age.
- •NYHA Class II or III or NYHA class IV symptoms.
- •A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
- •Qualifying Baseline RHC.
- •Qualifying echocardiogram
- •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
Exclusion Criteria
- •A diagnosis of PH WHO Groups 1, 3, 4, or
- •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.
Arms & Interventions
Placebo
Placebo
Intervention: Placebo (Drug)
TNX-103
oral levosimendan
Intervention: TNX-103 (Drug)
Outcomes
Primary Outcomes
Change in Six-minute walk distance
Time Frame: 12 weeks
Secondary Outcomes
- Clinical Worsening Events(12 weeks)
- KCCQ(12 weeks)
- Clinical Worsening Events(12 weeks)
- Change in NT-proBNP(12 weeks)
- Change NYHA functional class(12 weeks)
- KCCQ(12 weeks)
- Change in NT-proBNP(12 weeks)
- Change NYHA functional class(12 weeks)