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Trial record 1 of 1 for:    TNX-103
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LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF (LEVEL)

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ClinicalTrials.gov Identifier: NCT05983250
Recruitment Status : Recruiting
First Posted : August 9, 2023
Last Update Posted : May 20, 2024
Sponsor:
Collaborators:
Medpace, Inc.
Northwestern University
Information provided by (Responsible Party):
Tenax Therapeutics, Inc.

Study Description
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Brief Summary:
This study will evaluate the efficacy of TNX-103 (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).

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: TNX-103 Drug: Placebo Phase 3

Detailed Description:

This is a Phase 3, double-blind, randomized, placebo-controlled study of 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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind, randomized, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The blind is maintained by the use of a matching placebo.
Primary Purpose: Treatment
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)
Actual Study Start Date : January 10, 2024
Estimated Primary Completion Date : March 2027
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo
Active Comparator: TNX-103
levosimendan
 Drug: TNX-103
levosimendan 1 mg


Outcome Measures
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Primary Outcome Measures :
  1. Six-minute walk distance from Baseline to Week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. KCCQ [ Time Frame: 12 weeks ]
    Change in KCCQ - Overall Summary Score

  2. Clinical Worsening Events [ Time Frame: 12 weeks ]
  3. Change in NT-proBNP [ Time Frame: 12 weeks ]
    Decreases in NT-proBNP may indicate an improvement insymptoms

  4. Change NYHA functional class [ Time Frame: 12 weeks ]
    On a scale of I-IV. Lower scores may indicate improvement in symptoms


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women, greater than or equal to18 to 85 years of age.
  2. NYHA Class II or III or ambulatory NYHA class IV symptoms.
  3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
  4. A qualifying Baseline RHC performed within 120 days. The RHC can be a historical RHC done prior to study consent.
  5. A qualifying echocardiogram performed within 30 days showing an LVEF greater than or equal to 40%
  6. A qualifying 6-MWD of at least 100 meters, but not more than 450 meters at Screening
  7. A 48-hour ambulatory cardiac rhythm monitor during the Screening Period to establish the resting heart rate (HR) and rhythm.
  8. Chronic medications for heart failure with preserved ejection fraction (HFpEF) or other serious underlying cardiac or pulmonary conditions should be administered at a stable dose for greater than or equal to 30 days prior to the day of the Baseline 6-MWT.
  9. Female subjects of childbearing potential must have a negative urine pregnancy test result at the Screening Visit and a negative urine pregnancy test and must not be pregnant, lactating, or planning a pregnancy from the Screening Visit to 7 months after the last dose of study drug.
  10. Female subjects of childbearing potential will be included if they are either sexually inactive (abstinent) for 90 days prior to the first dose of study drug, or are using a highly effective birth control method
  11. Female subjects of nonchildbearing potential will be included if they meet the following definition of nonchildbearing potential: are either surgically sterile or postmenopausal.
  12. Male patients with female partners of childbearing potential must use highly effective methods of birth control during their participation in the study and for a period of 4 months after the last dose of study drug.
  13. Patients must agree to abstain from egg or sperm donation through 7 months for female patients and 4 months for male patients after administration of the last dose of study drug.
  14. Ability to adhere to study visit schedule and understand and comply with all protocol requirements.
  15. Signed informed consent document indicating that they understand the purpose and procedures required for the study and are willing to participate in the study.

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.
  3. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
  4. Structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous) within the past 12 months. OR, planned valve intervention in the next 6 months. OR, the presence of echocardiographic findings of significant valve disease as assessed from the qualifying echocardiogram

  5. Any of the following clinical laboratory values within 30 days as specified:

    1. Hemoglobin <10 g/dL
    2. Serum alanine aminotransferase or aspartate aminotransferase levels >3× upper limit of normal (ULN) or total bilirubin >3× ULN.
    3. Electrocardiogram (ECG) with a QTcF >450 msec for males and >470 msec for females at Screening and Baseline in the absence of right bundle branch block.
    4. Platelet count <75,000/mm3.
  6. A diagnosis of pre-existing lung disease
  7. Recent documentation of significant underlying lung disease
  8. Documentation of pulmonary thromboembolism in the last 12 months
  9. Cardiovascular co-morbidities
  10. Receipt of any approved pulmonary arterial hypertension-specific therapies
  11. Hospitalization for any indication within 30 days
  12. Receipt of any intravenous (IV) inotropes within 30 days
  13. Body mass index greater than or equal to 45 kg/m2.
  14. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
  15. Known history of chronic liver disease
  16. Prior exposure to levosimendan
  17. Current enrollment in or completion of any other investigational product study within 30 days of Screening.
  18. Initiation of an exercise program for cardiopulmonary rehabilitation within 45 days
  19. History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product.
  20. Major surgery within 60 days. Subjects must have completely recovered from any previous surgery.
  21. Prior heart, lung, or heart-lung transplants or life expectancy of <12 months
  22. Pregnancy or breastfeeding in females
  23. History of active malignancy, with the exception of fully treated basal cell carcinoma, cervical carcinoma in situ, or squamous cell carcinomas of the skin.
  24. History of clinically significant other diseases that may limit or complicate participation in the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05983250


Contacts
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Contact: Kevin Crawford 19198552145 k.crawford@tenaxthera.com
Contact: Douglas Hay, PhD 19198552110 d.hay@tenaxthera.com

Locations
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Sponsors and Collaborators
Tenax Therapeutics, Inc.
Medpace, Inc.
Northwestern University
More Information
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Responsible Party: Tenax Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05983250    
Other Study ID Numbers: TNX-103-06
First Posted: August 9, 2023    Key Record Dates
Last Update Posted: May 20, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tenax Therapeutics, Inc.:
HFpEF
Pulmonary hypertension group 2
PH-HFpEF
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases