A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Heart, Heart Failure With Preserved Ejection Fraction (HFPEF)
In brief
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
Key facts
- Study ID
- NCT07219511
- Run by
- Vasa Therapeutics
- People needed
- 42
- Starts
- 2025-11-04
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-04-09
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 with evidence of heart failure
- 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.
You may not qualify if…
- 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.
- Active chronic viral infection such as Hepatitis B, 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.
Where it is running
- Cardiology and Medicine Clinic — Little Rock, Arkansas, United States (enrolling)
- National Institute of Clinical Research — Huntington Beach, California, United States (enrolling)
- FOMAT — Santa Maria, California, United States (enrolling)
- Invivocure LLC — Van Nuys, California, United States (enrolling)
- New Generation of Medical Research — Hialeah, Florida, United States (enrolling)
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States (enrolling)
- Amavita Health — North Miami Beach, Florida, United States (enrolling)
- Broward Research Center — Pembroke Pines, Florida, United States (enrolling)
- Eagle Clinical Research — Chicago, Illinois, United States (enrolling)
- Chicago Medical Research — Hazel Crest, Illinois, United States (enrolling)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- LinQ Research, LLC — Tomball, Texas, United States (enrolling)
- Louisiana Heart Center — Slidell, Louisiana, United States (enrolling)
- Washington University — St Louis, Missouri, United States (enrolling)
- Ash Research Clinic — Brick, New Jersey, United States (enrolling)
- Erie County Medical Center — Buffalo, New York, United States (enrolling)
- Duke University Medical Center — Durham, North Carolina, United States (enrolling)
- Wake Forest — Winston-Salem, North Carolina, United States (enrolling)
- Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States (enrolling)
- Methodist Medical Center of Illinois — Peoria, Illinois, United States
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.