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Could a cannabidiol drug help heal inflamed hearts?

NCT ID NCT05180240

Disease control Sponsor: Cardiol Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests whether CardiolRx, a pharmaceutical cannabidiol, can improve heart recovery in adults with acute myocarditis (heart muscle inflammation). Participants receive either CardiolRx or a placebo for 12 weeks. The study uses heart MRI scans to measure changes in heart tissue and function.

What this could mean

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

Active substance
CardiolRx (cannabidiol)
What this could lead to
If it works, this could point toward a new treatment to help the heart heal better after acute myocarditis.
What could go wrong
This is a phase 2 trial with 109 participants, so results are still early and may not confirm benefit. Side effects of cannabidiol are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

109 people

The number who actually took part.

Started

Jul 2022

Finished

Feb 2025

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

18 to 75 years

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: 1. Males and females 18 years of age or older 2. Diagnosed with acute myocarditis including: 1. Clinical criteria (symptoms of chest pain, arrhythmia or shortness of breath, or history of viral-like illness), preferably followed by elevated troponin PLUS 2. CMR diagnosis (Lake Louise Criteria) within 10 days prior to randomization OR 3. Endomyocardial biopsy (EMB) showing either cellular inflammation and/or immunohistochemistry consistent with inflammation. 3. Male subjects with partners of childbearing potential who have had a vasectomy or are willing to use double barrier contraception methods during the conduct of the study and for 2 months after the last dose of study drug. 4. Women of childbearing potential willing to use an acceptable method of contraception starting with study drug administration and for a minimum of 2 months after study completion. Otherwise, women must be post- menopausal. Exclusion Criteria: 1. Coronary artery disease (CAD) defined as a stenosis greater than 50% in a major epicardial coronary artery 2. Severe valvular heart disease 3. Inability to safely undergo CMR including administration of gadolinium 4. Estimated glomerular filtration rate (eGFR) \< 30 ml/min 5. Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal (ULN) or ALT or AST \>3x ULN plus bilirubin \>2x ULN. 6. Sepsis, defined as documented bacteremia at the time of presentation or other documented active infection. 7. Severe left ventricular (LV) dysfunction requiring inotropic support, left ventricular assist device (LVAD) or other circulatory assist devices, or urgent need for transplantation 8. Documented biopsy evidence of giant cell or eosinophilic myocarditis 9. Prior history of sustained ventricular arrhythmia 10. Acute coronary syndrome within 30 days 11. Percutaneous coronary intervention within 30 days 12. History of QT interval prolongation or QTc interval \> 500 msec 13. Treated with strong inducers CYP3A4 or CYP2C19, as listed in Appendix 17.8 14. Treated with digoxin and/or type 1 or 3 antiarrhythmics 15. Current participation in any research study involving investigational drugs or devices 16. Inability or unwillingness to give informed consent 17. Ongoing drug or alcohol abuse 18. Women who are pregnant or breastfeeding 19. Current diagnosis of cancer, with the exception of non-melanoma skin cancer 20. Any factor, which would make it unlikely that the patient can comply with the study procedures 21. On any cannabinoid during the past month 22. Body weight \> 170 kg 23. Showing suicidal tendency as per the C-SSRS, administered at screening

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Conditions

The condition(s) this trial relates to.

acute myocarditis

As listed by the trial registrant

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

Acute myocarditis

Contacts and locations

Locations

  • Barzilai Medical Center

    Ashkelon, 7830604, Israel

  • Beilinson Hospital, Rabin medical Center

    Petah Tikva, 4941492, Israel

  • CHU de Montpellier

    Montpellier, 34295, France

  • Centre Hospitalier Universitaire de Nîmes

    Nîmes, 30029, France

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, France

  • Chu Rangueil

    Toulouse, France

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Complexo Hospitalar de Niterói

    Niterói, Rio de Janeiro, 24020-096, Brazil

  • Hopital Bichat Claude Bernard

    Paris, France

  • Hopital Louis Pradel Hospices Civils de Lyon

    Bron, 69500, France

  • Hospital Angelina Caron

    Campina Grande do Sul, Brazil

  • Hospital Felicio Rocho - Fundação Felice Rosso

    Belo Horizonte, Brazil

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

  • Hospital Nove de Julho

    São Paulo, São Paulo, 01409-002, Brazil

  • Hospital Pró-Cardíaco

    Rio de Janeiro, Brazil

  • Hospital Regional de São José

    São José, Brazil

  • Hospital São Lucas

    Porto Alegre, Brazil

  • Hospital de Clínicas de Porto Alegre (HCPA)

    Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

  • Hôpital Foch

    Suresnes, 92150, France

  • Hôpital Lariboisière - Département de Cardiologie

    Paris, 75475, France

  • Hôpital européen Georges-Pompidou

    Paris, France

  • Institut de Cardiologie hopital Pitié Salpêtrière

    Paris, France

  • Instituto D´Or de Pesquisa e Ensino

    Rio de Janeiro, 22281-100, Brazil

  • Instituto do Coração - InCor

    São Paulo, Brazil

  • Irmandade da Santa Casa de Misericórdia de São Paulo

    São Paulo, 01223-001, Brazil

  • Massachusetts General Hospital site

    Boston, Massachusetts, 02114, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • MedStar Heart and Vascular Institute

    Washington D.C., District of Columbia, 20010, United States

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • Nupec-Orizonti

    Belo Horizonte, Minas Gerais, 30210090, Brazil

  • PUC trials

    Curitiba, Paraná, 80230-130, Brazil

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Shamir Medical Center (Assaf Harofeh)

    Zrifin, 70300, Israel

  • Tel Aviv Sourasky Medical Center (Ichilov)

    Tel Aviv, 6423906, Israel

  • University of Alberta Hospital

    Edmonton, Alberta, T6G2B7, Canada

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

More trials for these conditions

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