RecruitingHeartHeart Failure With Preserved Ejection Fraction (HFPEF)

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

Eligible age

50+ yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

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

Sponsor: Vasa Therapeutics

✓ 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.

✕ 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