Status:
RECRUITING
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Lead Sponsor:
Vasa Therapeutics
Conditions:
Heart
Heart Failure With Preserved Ejection Fraction (HFPEF)
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
Eligibility Criteria
Inclusion
- Participants must meet all inclusion criteria to be eligible for trial participation.
- Males or females ≥ 50 years of age at the time of signing the informed consent.
- Diagnosis of HFpEF as defined by European Society of Cardiology or American College of Cardiology/American Heart Association criteria
- NYHA Functional Class II or III
- LVEF ≥ 50% demonstrated by echocardiography (ECHO) performed at Screening and evidence of heart failure with history of at least one HF hospitalization
- Elevated NT-proBNP at Screening
- NordicPRO-C6™ ≥ 11 ng/mL at Screening.
- Stable dose of all concomitant HF medications for at least 4 weeks prior to Screening.
- Body weight of at least 110 lbs (50 kg) and body mass index (BMI) within the range ≥ 18 to \< 45 kg/m2.
- Males must agree to the contraception requirements and females must be of non-childbearing potential
- Able to understand and willing to sign a written informed consent form (ICF).
- Willing and able to comply with trial procedures and restrictions listed in the ICF and in this protocol.
Exclusion
- Female trial participant who is pregnant or breastfeeding.
- Known hypersensitivity to VS-041.
- Cardiovascular disease other than HFpEF
- Active intercurrent illness such as acute bacterial or viral infection.
- History of illicit drug or alcohol abuse or addiction that in the opinion of the PI could affect participation.
- Serologic evidence of Hepatitis B or Hepatitis C or human immunodeficiency virus (HIV) at Screening.
- Acute decompensated HF within 30 days of Screening
- Lung disease within 12 months prior to Screening
- History of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
- 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.
- Have participated within the last 6 months in a clinical study involving an investigational product.
- Any other reason which, in the opinion of the PI, would prevent the participant from participating in the trial.
Key Trial Info
Start Date :
November 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT07219511
Start Date
November 4 2025
End Date
July 1 2026
Last Update
December 17 2025
Active Locations (18)
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1
National Institute of Clinical Research
Huntington Beach, California, United States, 92648
2
FOMAT
Santa Maria, California, United States, 93454
3
Invivocure LLC
Van Nuys, California, United States, 91405
4
New Generation of Medical Research
Hialeah, Florida, United States, 33016