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New pill for stiff heart condition enters human testing

NCT ID NCT07219511

Disease control Sponsor: Vasa Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new drug called VS-041 in 42 people aged 50 and older who have a type of heart failure where the heart pumps normally but is too stiff (HFpEF). The main goals are to check if the drug is safe and to measure changes in certain blood markers linked to heart health. Participants will take either a low or high dose of VS-041 or a placebo tablet twice daily.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VS-041 (a drug taken as a tablet twice daily)
What this could lead to
If successful, this could point toward a new treatment option for heart failure with preserved ejection fraction (HFpEF), a condition with few approved therapies.
What could go wrong
This is an early Phase 1 trial with only 42 participants, focused on safety and biomarkers—not on whether the drug actually improves symptoms or outcomes. Many drugs fail at this stage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

diastolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEART Heart failure with preserved ejection fraction (hfpef)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amavita Health

    RECRUITING

    North Miami Beach, Florida, 33169, United States

  • Ash Research Clinic

    RECRUITING

    Brick, New Jersey, 08724, United States

  • Broward Research Center

    RECRUITING

    Pembroke Pines, Florida, 33024, United States

  • Cardiology and Medicine Clinic

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • Chicago Medical Research

    RECRUITING

    Hazel Crest, Illinois, 60429, United States

  • Cleveland Clinic

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Eagle Clinical Research

    RECRUITING

    Chicago, Illinois, 60621, United States

  • Erie County Medical Center

    RECRUITING

    Buffalo, New York, 14215, United States

  • FOMAT

    RECRUITING

    Santa Maria, California, 93454, United States

  • Invivocure LLC

    RECRUITING

    Van Nuys, California, 91405, United States

  • Jacksonville Center for Clinical Research

    RECRUITING

    Jacksonville, Florida, 32216, United States

  • LinQ Research, LLC

    RECRUITING

    Tomball, Texas, 77375, United States

  • Louisiana Heart Center

    RECRUITING

    Slidell, Louisiana, 70458, United States

  • Methodist Medical Center of Illinois

    NOT_YET_RECRUITING

    Peoria, Illinois, 61606, United States

  • National Institute of Clinical Research

    RECRUITING

    Huntington Beach, California, 92648, United States

  • New Generation of Medical Research

    RECRUITING

    Hialeah, Florida, 33016, United States

  • Oklahoma Heart Hospital

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75231, United States

  • Wake Forest

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.