A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
NCT ID: NCT07219511
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
42 participants
INTERVENTIONAL
2025-10-31
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo
Placebo to match VS-041
Low Dose VS-041
VS-041
VS-041 high dose, VS-041 low dose or Placebo tablet BID
High Dose VS-041
VS-041
VS-041 high dose, VS-041 low dose or Placebo tablet BID
Interventions
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VS-041
VS-041 high dose, VS-041 low dose or Placebo tablet BID
Placebo
Placebo to match VS-041
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of HFpEF as defined by European Society of Cardiology or American College of Cardiology/American Heart Association criteria
3. NYHA Functional Class II or III
4. LVEF ≥ 50% demonstrated by echocardiography (ECHO) performed at Screening and evidence of heart failure with history of at least one HF hospitalization
5. Elevated NT-proBNP at Screening
6. NordicPRO-C6™ ≥ 11 ng/mL at Screening.
7. Stable dose of all concomitant HF medications for at least 4 weeks prior to Screening.
8. Body weight of at least 110 lbs (50 kg) and body mass index (BMI) within the range ≥ 18 to \< 45 kg/m2.
9. Males must agree to the contraception requirements and females must be of non-childbearing potential
10. Able to understand and willing to sign a written informed consent form (ICF).
11. Willing and able to comply with trial procedures and restrictions listed in the ICF and in this protocol.
Exclusion Criteria
2. Known hypersensitivity to VS-041.
3. Cardiovascular disease other than HFpEF
4. Active intercurrent illness such as acute bacterial or viral infection.
5. History of illicit drug or alcohol abuse or addiction that in the opinion of the PI could affect participation.
6. Serologic evidence of Hepatitis B or Hepatitis C or human immunodeficiency virus (HIV) at Screening.
7. Acute decompensated HF within 30 days of Screening
8. Lung disease within 12 months prior to Screening
9. History of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
10. History of any other condition including psychiatric disorders that, in the opinion of the PI, may preclude the participant from following and completing the protocol.
11. Have participated within the last 6 months in a clinical study involving an investigational product.
12. Any other reason which, in the opinion of the PI, would prevent the participant from participating in the trial.
50 Years
ALL
No
Sponsors
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Vasa Therapeutics
INDUSTRY
Responsible Party
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Locations
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National Institute of Clinical Research
Huntington Beach, California, United States
FOMAT
Santa Maria, California, United States
Invivocure LLC
Van Nuys, California, United States
New Generation of Medical Research
Hialeah, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Amavita Health
Miami, Florida, United States
Chicago Medical Research
Hazel Crest, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Louisiana Heart Center
Slidell, Louisiana, United States
Washington University
St Louis, Missouri, United States
Ash Research Clinic
Brick, New Jersey, United States
Erie County Medical Center
Buffalo, New York, United States
Duke University
Durham, North Carolina, United States
Wake Forest
Winston-Salem, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UT Southwestern
Dallas, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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VS-041-102
Identifier Type: -
Identifier Source: org_study_id