RecruitingPhase 1NCT07219511
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Sponsor
Vasa Therapeutics
Enrollment
42 participants
Start Date
Nov 4, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
Eligibility
Min Age: 50 Years
Plain Language Summary
Simplified for easier understanding
This study is testing a new drug called VS-041 in people with heart failure with preserved ejection fraction (HFpEF) — a type of heart failure where the heart pumps normally but is too stiff, leading to fluid buildup and symptoms like shortness of breath. The study is primarily looking at the safety and tolerability of the drug and how it affects biological markers of heart function.
**You may be eligible if...**
- You are 50 or older and have been diagnosed with HFpEF
- Your heart has a normal or near-normal pumping function (ejection fraction of 50% or higher) confirmed by echocardiogram
- You have moderate heart failure symptoms (NYHA Class II or III)
- Your heart failure medications have been stable for at least 4 weeks
- You have certain elevated blood markers indicating heart stress (NT-proBNP and NordicPRO-C6)
**You may NOT be eligible if...**
- You are pregnant, breastfeeding, or of childbearing potential (unless male or post-menopausal female)
- You have cardiovascular disease beyond HFpEF
- You have an active infection or active chronic viral infection (Hepatitis B, C, or HIV)
- You have a history of drug or alcohol addiction that could affect participation
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGVS-041
VS-041 high dose, VS-041 low dose or Placebo tablet BID
OTHERPlacebo
Placebo to match VS-041
Locations(21)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07219511