A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Sponsored by Vasa Therapeutics
About this study
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
Where this study is enrolling
- Call (773) 657-8993
Eagle Clinical Research
Chicago, Illinois
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Who can participate
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.
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Trial data sourced from ClinicalTrials.gov.