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

RECRUITINGPHASE1

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

NCT07219511•Vasa Therapeutics

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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).
+1 more criteria

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.
+2 more criteria

Locations (17)

Cardiology and Medicine Clinic

Little Rock, Arkansas, United States

National Institute of Clinical Research

Huntington Beach, California, United States

FOMAT

Santa Maria, California, United States

Invivocure LLC

Van Nuys, California, United States

New Generation of Medical Research

Hialeah, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Amavita Health

North Miami Beach, Florida, United States

Chicago Medical Research

Hazel Crest, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Louisiana Heart Center

Slidell, Louisiana, United States

Key Dates

Start Date

November 4, 2025

Primary Completion Date

June 1, 2026

Completion Date

July 1, 2026

Last Updated

February 24, 2026

Enrollment

ESTIMATED participants

Conditions

HeartHeart Failure With Preserved Ejection Fraction (HFPEF)

Interventions

VS-041

DRUG

Placebo

OTHER

Contacts

Clinical Team

CONTACT

760-230-3398 Clinical@Vasatherapeutics.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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