Clinical trial NCT05983250: LEVosimendan to Improve Exercise Limitation in Patients with PH-HFpEF
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pulmonary Hypertension
Keywords: HFpEF
Pulmonary hypertension group 2
PH-HFpEF
Heart Failure
Lead sponsor: Tenax Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
name: Northwestern University
First posted: 2023-08-09
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, randomized, placebo controlled
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Six-minute walk distance from Baseline to Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: KCCQ
timeFrame: 12 weeks
measure: Clinical Worsening Events
timeFrame: 12 weeks
measure: Change in NT-proBNP
timeFrame: 12 weeks
measure: Change NYHA functional class
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Tenax Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Tenax Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Tenax Investigational Site
state: Arkansas
city: Irvine
country: United States
facility: Tenax Investigational Site
state: California
city: La Jolla
country: United States
facility: Tenax Investigational Site
state: California
city: Los Angeles
country: United States
facility: Tenax Investigational Site
state: California
city: Los Angeles
country: United States
facility: Tenax Investigational Site
state: California
city: Sacramento
country: United States
facility: Tenax Investigational Site
state: California
city: San Francisco
country: United States
facility: Tenax Investigational Site
state: California
city: Washington DC
country: United States
facility: Tenax Investigational Site
state: District of Columbia
city: Jacksonville
country: United States
facility: Tenax Investigational Site
state: Florida
city: Tampa
country: United States
facility: Tenax Investigational Site
state: Florida
city: Tampa
country: United States
facility: Tenax Investigational Site
state: Florida
city: Winter Haven
country: United States
facility: Tenax Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Tenax Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Tenax Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Tenax Investigational Site
state: Illinois
city: Galesburg
country: United States
facility: Tenax Investigational Site
state: Illinois
city: Oak Lawn
country: United States
facility: Tenax Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Tenax Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Tenax Investigational Site
state: Indiana
city: Kansas City
country: United States
facility: Tenax Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Tenax Investigational Site
state: Kentucky
city: Boston
country: United States
facility: Tenax Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Tenax Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Tenax Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Tenax Investigational Site
state: Minnesota
city: Rochester
country: United States
facility: Tenax Investigational Site
state: Minnesota
city: St. Louis
country: United States
facility: Tenax Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Tenax Investigational Site
state: Nebraska
city: New York
country: United States
facility: Tenax Investigational Site
state: New York
city: New York
country: United States
facility: Tenax Investigational Site
state: New York
city: Rochester
country: United States
facility: Tenax Investigational Site
state: New York
city: Roslyn
country: United States
facility: Tenax Investigational Site
state: New York
city: Durham
country: United States
facility: Tenax Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Tenax Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Tenax Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Tenax Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Tenax Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Tenax Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Tenax Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Tenax Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: Tenax Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: Tenax Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Tenax Investigational Site
state: Texas
city: Dallas
country: United States
facility: Tenax Investigational Site
state: Texas
city: Lubbock
country: United States
facility: Tenax Investigational Site
state: Texas
city: Plano
country: United States
facility: Tenax Investigational Site
state: Texas
city: Murray
country: United States
facility: Tenax Investigational Site
state: Utah
city: Richmond
country: United States
facility: Tenax Investigational Site
state: Virginia
city: Madison
country: United States
facility: Tenax Investigational Site
state: Wisconsin
city: Winnipeg
country: Canada
facility: Tenax Investigational Site
state: Manitoba
city: London
country: Canada
facility: Tenax Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Tenax Investigational Site
state: Ontario
Study officials:
References: