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Study on the Effect of Cannabidiol (CardiolRx) on Heart Recovery in Patients with Acute Myocarditis

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment called CardiolRx on patients with a heart condition known as Acute Myocarditis. Acute Myocarditis is an inflammation of the heart muscle that can cause symptoms like chest pain, irregular heartbeats, or shortness of breath. The treatment being tested, CardiolRx, is a solution containing Cannabidiol, a chemical compound that is being investigated for its potential benefits in heart recovery.

The purpose of this study is to evaluate how effective CardiolRx is in helping the heart recover in patients who have Acute Myocarditis and to ensure that it is safe to use in the proposed doses. The study is designed to compare the effects of CardiolRx with a placebo, which means some participants will receive the active treatment while others will receive an inactive substance. This helps researchers understand the true effects of the treatment.

Participants in the study will take the treatment orally for a period of up to 12 weeks. During this time, their heart health will be monitored using a technique called Cardiac Magnetic Resonance (CMR), which is a type of imaging that provides detailed pictures of the heart. The study aims to measure changes in the heart's structure and function to determine the impact of CardiolRx on heart recovery. The trial is expected to continue until early 2025.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting the eligibility criteria, which include being 18 years or older and having a diagnosis of acute myocarditis. This diagnosis may be confirmed through symptoms, elevated troponin levels, cardiac magnetic resonance (CMR) imaging, or an endomyocardial biopsy.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the active treatment, CardiolRx, or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the active treatment.

  3. Step 3

    Treatment administration

    CardiolRx is administered orally in the form of a solution. The specific dosage and frequency are determined by the study protocol and are designed to evaluate the effect on myocardial recovery and ensure safety.

  4. Step 4

    Monitoring and assessments

    Participants undergo regular monitoring and assessments throughout the study. This includes measuring the primary outcomes, which are the differences in extracellular volume (ECV) and global longitudinal strain (GLS) using cardiac magnetic resonance (CMR) imaging at 12 weeks post-randomization.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by January 31, 2025. Participants are required to continue using contraception for a minimum of 2 months after the last dose of the study drug, if applicable.

Who can join the trial?

6 criteria

  • Men and women who are 18 years old or older.
  • Must have been diagnosed with acute myocarditis, which is a condition where the heart muscle becomes inflamed. This diagnosis can be made through:
    • Clinical criteria, which means having symptoms like chest pain, irregular heartbeat, or shortness of breath, or having had a recent illness that felt like a virus. This should ideally be followed by a blood test showing high levels of a protein called troponin.
    • CMR diagnosis, which stands for Cardiac Magnetic Resonance, a type of heart scan, done within 10 days before joining the study.
    • Endomyocardial biopsy, which is a small tissue sample from the heart showing signs of inflammation.
    • Men with partners who can have children must have had a vasectomy or agree to use two forms of birth control during the study and for 2 months after the last dose of the study drug.
    • Women who can have children must agree to use an acceptable form of birth control starting when they begin the study drug and for at least 2 months after finishing the study. If not, they must be postmenopausal, which means they haven't had a period for at least a year, or be surgically sterile. Acceptable birth control methods include injections, pills, patches, implants, devices placed inside the body, surgical procedures, or complete abstinence from sex. Methods like tracking the menstrual cycle are not acceptable for this study. These rules also apply to female partners of male participants.

Who cannot join the trial?

10 criteria

  • Patients who have a history of **allergic reactions** to the study medication or its ingredients. An allergic reaction is when your body reacts negatively to something, causing symptoms like rash, itching, or difficulty breathing.
  • Patients with **severe liver disease**. This means the liver, which helps clean your blood and digest food, is not working well.
  • Patients with **severe kidney disease**. This means the kidneys, which help filter waste from your blood, are not functioning properly.
  • Patients who are **pregnant or breastfeeding**. This is to ensure the safety of both the mother and the baby.
  • Patients who have participated in another clinical trial within the last 30 days. This is to avoid any interference with the results of the study.
  • Patients with **uncontrolled high blood pressure**. This means blood pressure that is not being managed well with medication or lifestyle changes.
  • Patients with **active infections**. This means having an infection that is currently causing symptoms and may need treatment.
  • Patients with **cancer** that is not in remission. Remission means that the signs and symptoms of cancer are reduced or gone.
  • Patients with **heart conditions** other than acute myocarditis that could interfere with the study. Acute myocarditis is an inflammation of the heart muscle.
  • Patients who are unable to follow the study procedures or attend the required visits. This is important to ensure accurate and complete data collection.
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Investigated drugs

CardiolRx is being studied for its potential to help the heart recover in patients who have acute myocarditis, which is an inflammation of the heart muscle. The trial aims to see if CardiolRx can improve heart function and ensure that it is safe for patients to use.

What is already known about the treatment

CardiolRx – CardiolRx is administered orally in the form of capsules. It is currently being studied in clinical trials for its potential benefits in treating acute myocarditis, a condition characterized by inflammation of the heart muscle. The main therapeutic indication for CardiolRx is to aid in myocardial recovery, helping the heart muscle heal and function better. At the molecular level, CardiolRx is believed to work by reducing inflammation and oxidative stress in the heart tissue, although the exact mechanism is still under investigation. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Acute Myocarditis – Acute myocarditis is an inflammation of the heart muscle, often caused by viral infections, which can lead to a reduction in the heart's ability to pump blood effectively. This condition may result in symptoms such as chest pain, fatigue, shortness of breath, and irregular heartbeats. The inflammation can cause damage to the heart muscle, potentially leading to heart failure if not addressed. In some cases, the inflammation may resolve on its own, while in others, it can persist and cause long-term heart issues. The progression of acute myocarditis can vary greatly among individuals, with some experiencing mild symptoms and others facing more severe complications. Monitoring and supportive care are often necessary to manage the condition effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514639-10-00Protocol codeCardiol 100-002Estimated enrolment100 patientsSponsorCardiol Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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