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Acute MyocarditisPhase 2ARCHERNCT05180240

Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis

A Phase 2 study testing CardiolRx in people with Acute Myocarditis, run by Cardiol Therapeutics Inc. at 37 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Multi-center, double-blind, placebo-controlled, parallel group design. Patients with myocarditis will be screened and, if eligible, randomized within 10 days of the diagnostic CMR to CardiolRx or placebo. CardiolRx is pharmaceutically produced Cannabidiol and is free of tetrahydrocannabinol (THC<5 ppm). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Myocarditis
What is being tested?
CardiolRx
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
109 participants
Where
37 sitesin 5 countries
Study dates
28 Jul 2022to 4 Feb 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females 18 years of age or older
  • Diagnosed with acute myocarditis including:
  • Clinical criteria (symptoms of chest pain, arrhythmia or shortness of breath, or history of viral-like illness), preferably followed by elevated troponin PLUS
  • CMR diagnosis (Lake Louise Criteria) within 10 days prior to randomization OR
  • Endomyocardial biopsy (EMB) showing either cellular inflammation and/or immunohistochemistry consistent with inflammation.
  • 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.
  • 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.

Who cannot join

  • Coronary artery disease (CAD) defined as a stenosis greater than 50% in a major epicardial coronary artery
  • Severe valvular heart disease
  • Inability to safely undergo CMR including administration of gadolinium
  • Estimated glomerular filtration rate (eGFR) < 30 ml/min
  • 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.
  • Sepsis, defined as documented bacteremia at the time of presentation or other documented active infection.
Show all 23Show fewer
  • Severe left ventricular (LV) dysfunction requiring inotropic support, left ventricular assist device (LVAD) or other circulatory assist devices, or urgent need for transplantation
  • Documented biopsy evidence of giant cell or eosinophilic myocarditis
  • Prior history of sustained ventricular arrhythmia
  • Acute coronary syndrome within 30 days
  • Percutaneous coronary intervention within 30 days
  • History of QT interval prolongation or QTc interval > 500 msec
  • Treated with strong inducers CYP3A4 or CYP2C19, as listed in Appendix 17.8
  • Treated with digoxin and/or type 1 or 3 antiarrhythmics
  • Current participation in any research study involving investigational drugs or devices
  • Inability or unwillingness to give informed consent
  • Ongoing drug or alcohol abuse
  • Women who are pregnant or breastfeeding
  • Current diagnosis of cancer, with the exception of non-melanoma skin cancer
  • Any factor, which would make it unlikely that the patient can comply with the study procedures
  • On any cannabinoid during the past month
  • Body weight > 170 kg
  • Showing suicidal tendency as per the C-SSRS, administered at screening

Trial locations and contacts

37 sites in 5 countries.

37 sites in 5 countries

Brazil14 sites

  • Nupec-Orizonti

    Belo Horizonte, Minas Gerais, 30210090

  • Hospital Felicio Rocho - Fundação Felice Rosso

    Belo Horizonte

  • Hospital Angelina Caron

    Campina Grande do Sul

  • PUC trials

    Curitiba, Paraná, 80230-130

  • Complexo Hospitalar de Niterói

    Niterói, Rio de Janeiro, 24020-096

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Hospital de Clínicas de Porto Alegre (HCPA)

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Hospital São Lucas

    Porto Alegre

  • Instituto D´Or de Pesquisa e Ensino

    Rio de Janeiro, 22281-100

  • Hospital Pró-Cardíaco

    Rio de Janeiro

  • Hospital Regional de São José

    São José

  • Hospital Nove de Julho

    São Paulo, São Paulo, 01409-002

  • Irmandade da Santa Casa de Misericórdia de São Paulo

    São Paulo, 01223-001

  • Instituto do Coração - InCor

    São Paulo

Other trials in Brazil

France10 sites

  • Hopital Louis Pradel Hospices Civils de Lyon

    Bron, 69500

  • CHU de Montpellier

    Montpellier, 34295

  • Centre Hospitalier Universitaire de Nîmes

    Nîmes, 30029

  • Hôpital Lariboisière - Département de Cardiologie

    Paris, 75475

  • Hopital Bichat Claude Bernard

    Paris

  • Hôpital européen Georges-Pompidou

    Paris

  • Institut de Cardiologie hopital Pitié Salpêtrière

    Paris

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers

  • Hôpital Foch

    Suresnes, 92150

  • Chu Rangueil

    Toulouse

Other trials in France

United States6 sites

  • Massachusetts General Hospital site

    Boston, Massachusetts, 02114

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • MedStar Heart and Vascular Institute

    Washington D.C., District of Columbia, 20010

Other trials in United States

Israel5 sites

  • Barzilai Medical Center

    Ashkelon, 7830604

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Beilinson Hospital, Rabin medical Center

    Petah Tikva, 4941492

  • Tel Aviv Sourasky Medical Center (Ichilov)

    Tel Aviv, 6423906

  • Shamir Medical Center (Assaf Harofeh)

    Zrifin, 70300

Other trials in Israel

Canada2 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G2B7

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

Official title: Impact of CardiolRx on Myocardial Recovery in Acute Myocarditis. A Double-blind, Placebo-controlled Trial

Multi-center, double-blind, placebo-controlled, parallel group design. Patients with myocarditis will be screened and, if eligible, randomized within 10 days of the diagnostic CMR to CardiolRx or placebo.

CardiolRx is pharmaceutically produced Cannabidiol and is free of tetrahydrocannabinol (THC<5 ppm). The treatment period is 12 weeks; a last follow-up visit is scheduled one week after the last treatment, 13 weeks after randomization. Study assessments include Cardiac Magnetic Resonance imaging (CMR), ECG monitoring, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as physical exams and laboratory tests.

The primary and secondary outcome parameters are measured by CMR. Additional outcomes include clinical endpoints and changes in inflammatory and biomarkers.

Read the detailed description

Rationale:

Myocarditis is an acute inflammatory condition of the myocardium. Presentation of the disease may be fulminant and necessitate cardiac support, or even result in sudden cardiac death; milder cases are usually self-limiting but may progress to dilated cardiomyopathy with eventual end-stage heart failure. Other than treatments for associated heart failure there are no specific indicated treatments for myocarditis. CardiolRxTM (cannabidiol [CBD] solution), which is known to have anti-inflammatory properties, is being investigated to treat the underlying inflammatory process and thereby favorably modify acute myocarditis. The primary endpoints of the trial are cardiac magnetic resonance measures of left ventricular systolic function (ejection fraction and longitudinal strain) and myocardial edema (extra cellular volume) which have been shown to predict long term prognosis of patients with acute myocarditis.

Multi-center, double-blind, randomized, placebo-controlled, parallel group design. 1:1 randomization; treatment will be stratified within sites.

Patients diagnosed with acute myocarditis by a biopsy or a CMR will be screened within 10 days of the diagnostic CMR. Informed consent will be obtained at this point. For patients who have been diagnosed using an EMB, a CMR needs to be performed as well, which will be included in the informed consent form (ICF).Eligible patients will then be randomized within 10 days from the CMR assessment.

Baseline assessments include the following: Clinical assessment, including vital signs, ECG, 24-hr Holter, chest x-ray; Hematology and blood chemistry, NYHA classification, C SSRS and KCCQ. Frozen plasma will be retained for central analysis of hs-troponin, NT-proBNP and inflammatory markers.

Study treatment needs to be taken with food and will be initiated in the evening of Day 1, after all baseline assessments have been completed and the patient has been randomized.

Oral administration is as follows:

  • Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
  • Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
  • Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21):

7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo • Week 4 to end of treatment period (p.m. dose of Day 21 to

a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo

If the next higher dose after each study drug increase is not tolerated, the dose will be reduced to the previous tolerated dose.

Every week (before the next dose increase) the patient will be re-evaluated. This includes ECG monitoring at approximately 5 hours post-morning dose (time of Tmax) to surveil for deleterious effects on ECG intervals (particularly the QTc interval) and rhythm. Drug titration will be dependent on investigator or designate interrogation of the ECGs and the absence of new, clinically significant abnormalities on those ECGs.

Vital signs, concurrent medication and Adverse Events (AEs), including Serious Adverse Events (SAEs) will be recorded, blood chemistry including liver function tests, hematology as well as INR assessments will be carried out.

Final efficacy assessments (including a second CMR) will take place after 12 weeks of study treatment. A final safety assessment will take place after 13 weeks, 1 week after completion of study treatment.

Being tested
CardiolRx
Keywords
Pharmaceutically produced CBC, THC < 5ppm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CardiolRxDrug

    Also called Cannabidiol

    Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.

Study groups in NCT05180240
Study groupRoleWhat they receive
CardiolRxExperimental* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
Receives: Drug: CardiolRx
PlaceboPlacebo comparator* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
Receives: Drug: CardiolRx

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Extracellular Volume (ECV)

    Change of ECV from baseline at 12 weeks, measured by cardiac Cardiac MRI. ECV is measuring the degree of edema and fibrosis. The unit of measure was percentage. It was the percentage of myocardial tissue that is extracellular space (i.e. fraction of the myocardium occupied by extracellular matrix and interstitial fluid).

    Measured: 12 weeks post randomization

  2. Global Longitudinal Strain (GLS)

    The outcome was the change in GLS from baseline at 12 weeks, measured by cardiac Cardiac MRI. GLS is a predictor of cardiac function. The unit of measure is percentage. It is the percent change in myocardial length relative to its original (end-diastolic) length along the long axis.

    Longitudinal strain during systole is usually negative, because the ventricle shortens; normal peak GLS in healthy adults is around -20% (i.e., 20% shortening relative to original length)

    Measured: 12 weeks post randomization

Secondary outcomes (1)

  1. Change in Left-ventricular Ejection Fraction (LVEF) From Baseline at 12 Weeks

    Left-ventricular ejection fraction (LVEF) as measured by Cardiac MRI at 12 weeks. LVEF is a measure of cardiac function. The unit of measure is percentage. It is the percent of end-diastolic blood volume in the left ventricle that is ejected with each systolic contraction. Mathematically, LVEF = (stroke volume/end-diastolic volume) x 100.

    Measured: 12 weeks post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2022
  2. Study start28 Jul 2022
  3. Primary completion31 Jan 2025
  4. Study completion4 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multi-center, double-blind, randomized, placebo-controlled, parallel group design. 1:1 randomization
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05180240
Sponsor's protocol ID
Cardiol 100-002
Acronym
ARCHER
Status last verified
Sep 2026
First submitted
25 Sep 2021
Last updated
30 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee WS, Erdelyi K, Matyas C, Mukhopadhyay P, Varga ZV, Liaudet L, Hasku G, Cihakova D, Mechoulam R, Pacher P. Cannabidiol Limits T Cell-Mediated Chronic Autoimmune Myocarditis: Implications to Autoimmune Disorders and Organ Transplantation. Mol Med. 2016 Sep;22:136-146. doi: 10.2119/molmed.2016.00007. Epub 2016 Jan 8.

    PubMed 26772776

  • McNamara DM, Cooper LT, Friedrich MG, Arbel Y, Bhimaraj A, Bocchi E, Hamer A, Herdy AH, Kerneis M, Liu PP, Parker AB, Pocock SJ, Smith ER, Tang WHW, Torre-Amione G, Tschope C; ARCHER Study Group. Impact of cannabidiol on myocardial recovery in patients with acute myocarditis: primary results of the ARCHER study. ESC Heart Fail. 2026 Feb 3;13(1):xvaf034. doi: 10.1093/eschf/xvaf034.

    PubMed 41711722

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CardiolRx in people with Acute Myocarditis, run by Cardiol Therapeutics Inc. at 37 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Brazil, France, United States, Israel, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extracellular Volume (ECV) (time frame: 12 weeks post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05180240, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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