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VS-041 safety and biomarker test for adults with HFpEF

A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Phase 1 Interventional Vasa Therapeutics · NCT07219511

This test tries VS-041 to see if it is safe, tolerable, and changes heart-failure biomarkers in people 50 and older with HFpEF.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment42 (estimated)
Ages50 Years and up
SexAll
SponsorVasa Therapeutics Industry-sponsored
Locations21 sites (Little Rock, Arkansas and 20 other locations)
Trial IDNCT07219511 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional trial gives adults with HFpEF either VS-041 or placebo and monitors safety, tolerability, and biomarker responses. Eligible participants must be 50 or older with LVEF ≥50%, NYHA class II–III symptoms, elevated NT-proBNP, and a NordicPRO-C6 ≥11 ng/mL, and must be on stable heart-failure medications. Blood biomarkers, echocardiography, and clinical assessments will be collected at screening and follow-up visits to track safety signals and any biological activity. The study is sponsored by Vasa Therapeutics and is conducted at three U.S. cardiology clinics.

Who should consider this trial

Good fit: Adults aged 50 and over with a clinical diagnosis of HFpEF (LVEF ≥50%), NYHA class II–III symptoms, elevated NT-proBNP and NordicPRO-C6 ≥11 ng/mL, stable heart-failure medications, and BMI 18–45 kg/m2 are ideal candidates.

Not a fit: People younger than 50, with LVEF below 50%, NYHA class I or IV, unstable heart-failure medications, pregnant or of childbearing potential not meeting contraception requirements, or with BMI outside 18–45 kg/m2 are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, VS-041 could offer a new, safe treatment approach that improves biomarkers linked to HFpEF and help advance therapies to reduce symptoms.

How similar studies have performed: Similar early-phase biomarker-driven approaches in HFpEF are relatively novel and prior drug trials in HFpEF have had mixed results, so clear precedents of success are limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Participants must meet all inclusion criteria to be eligible for trial participation.

1. Males or females ≥ 50 years of age at the time of signing the informed consent.
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 with evidence of heart failure
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:

1. Female trial participant who is pregnant or breastfeeding.
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. Active chronic viral infection such as Hepatitis B, 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.

Where this trial is running

Little Rock, Arkansas and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HeartHeart Failure With Preserved Ejection FractionHeart Failure with Preserved Ejection FractionHFpEF
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.