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Study of Cannabidiol for Treatment of Recurrent Pericarditis in Affected Patients

Verified siteInvestigationalNo placebo
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What is this trial about?

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

The study looks at people who have Recurrent Pericarditis, a condition where the lining around the heart becomes inflamed repeatedly, causing chest pain. The treatment being tested is an oral solution called CardiolRx, which contains the substance cannabidiol. The main goal of the research is to see how this medication affects the pain and inflammation associated with the disease.

Participants will take the medication for several weeks and will be asked to rate their chest pain using an 11‑point NRS, a simple scale where 0 means no pain and 10 means the worst pain imaginable. Blood tests will also be done to measure CRP, a protein that rises when there is inflammation in the body, to see if it returns to normal levels. The study follows subjects for about six months, with check‑ins at the start, after eight weeks, and at the end, allowing researchers to track changes in pain scores and inflammation over time.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After joining the study, you will complete a consent form and provide information about your medical history and current health.

    A baseline evaluation will be performed, which includes measuring your pericarditis pain using an 11‑point numeric rating scale (nrs) and, if applicable, a blood test to determine the level of c‑reactive protein (crp).

  2. Step 2

    Start of medication

    You will begin taking cardiolrx, which contains the active substance cannabidiol.

    The medication is provided as an oral solution and is dosed at 20 mg per kilogram of body weight each day, taken as directed by the study team.

  3. Step 3

    Regular pain and safety monitoring

    Throughout the study you will record your pericarditis pain each day using the 11‑point nrs.

    If you had an elevated crp level at baseline, periodic blood samples will be taken to monitor changes in crp.

  4. Step 4

    8‑week visit

    At week 8 you will return for a study visit.

    Your pain score will be recorded again and compared with the baseline value.

    A blood test will be performed to check whether the crp level has returned to normal (for those who started with a level of 1.0 mg/dl or higher).

  5. Step 5

    Continuation of treatment to 26 weeks

    You will continue taking cardiolrx for a total of 26 weeks.

    Pain assessments and, when needed, crp measurements will continue during this period.

  6. Step 6

    26‑week visit

    At week 26 a final study visit will be conducted.

    Pain will be rated again using the 11‑point nrs.

    A blood sample will be taken to evaluate the crp level and to determine the overall change from baseline.

    The study will also record whether any pericarditis recurrences have occurred during the extension period.

  7. Step 7

    Extension period monitoring

    After the 26‑week visit, you may be asked to continue reporting any new episodes of pericarditis.

    Additional follow‑up visits may be scheduled to assess long‑term safety and effectiveness of the treatment.

Who can join the trial?

7 criteria

  • Be 18 years of age or older, male or female.
  • Have been diagnosed with at least two episodes of recurrent pericarditis.
  • In the past 7 days, have had at least one day with chest pain from pericarditis that you rate 4 or higher on an 11‑point Numerical Rating Scale (NRS) (0 = no pain, 10 = worst pain).
  • Show either a blood test called C‑Reactive Protein (CRP) that is 1.0 mg/dL or higher in the past week, or have imaging evidence of heart‑lining inflammation on a cardiac magnetic resonance imaging (CMR) scan (a special heart MRI that looks for swelling).
  • Currently be taking non‑steroidal anti‑inflammatory drugs (NSAIDs), colchicine, and/or corticosteroids for pericarditis, and the doses must be stable (not changed recently).
  • If you are a male who could father a child, you must have had a vasectomy or agree to use two forms of birth control (known as double barrier contraception) during the study and for two months after the last dose.
  • If you are a woman who could become pregnant, you must use a highly effective birth control method starting when you begin the study drug and continue for at least two months after the last dose, unless you are postmenopausal (no vaginal bleeding for at least one year and confirmed by a hormone test called follicle stimulating hormone (FSH) ≥40 mIU/mL) or have had surgery that makes you unable to become pregnant.

Who cannot join the trial?

19 criteria

  • Having pericarditis caused by certain conditions such as tuberculosis (TB) (a bacterial infection), cancer (neoplastic), pus‑filled infection (purulent), recent radiation therapy, a serious chest injury (like a car accident), or inflammation of the heart muscle (myocarditis).
  • Kidney function measured by estimated glomerular filtration rate (eGFR) that is lower than 30 mL/min, which means the kidneys are not filtering well.
  • Very high liver enzyme levels: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than five times the normal upper limit, or ALT/AST more than three times normal together with a high level of bilirubin (a substance that builds up when the liver is not working properly) that is more than two times normal.
  • Having a severe infection in the blood (sepsis) or any other active infection at the time of screening.
  • Past episodes of dangerous fast heart rhythms called sustained ventricular arrhythmias.
  • A history of a heart‑electrical problem called QT interval prolongation, which can lead to irregular beats.
  • A measured heart‑electrical interval called QTc that is longer than 500 milliseconds.
  • Currently taking part in another research study that uses experimental drugs or devices.
  • Being unable or unwilling to give informed consent (understanding the study and agreeing to join).
  • Having had seizures in the past or being diagnosed with a seizure disorder.
  • Being allergic (hypersensitivity) to any part of the study medication CardiolRx™, which contains cannabidiol.
  • Ongoing problems with drug or alcohol misuse.
  • Using any cannabis‑derived product (cannabinoid) within the past month.
  • Women who are currently pregnant or breastfeeding.
  • Having a current diagnosis of cancer, except for non‑melanoma skin cancer.
  • Any situation that would make it unlikely you could follow the study’s visits and procedures.
  • Showing signs of suicidal thoughts or behavior as measured by the Columbia Suicide Severity Rating Scale (C‑SSRS).
  • Taking the heart medication digoxin or any type 1 or type 3 anti‑arrhythmic drugs (medications used to control abnormal heart rhythms).
  • Taking medicines that suppress the immune system, such as Rilonacept, Anakinra, Canakinumab, Methotrexate, Azathioprine, Cyclosporine, or intravenous immune globulin (IVIG).
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Investigated drugs

CardiolRx is an oral liquid medication that contains cannabidiol, a compound derived from the cannabis plant. In this study, participants take the solution by mouth to see if it can help reduce the frequency and severity of recurrent pericarditis, which is inflammation of the heart’s outer lining. The trial is testing CardiolRx to evaluate its potential benefits for this heart condition.

What is already known about the treatment

CardiolRx - CardiolRx is taken as an oral solution, meaning the liquid is swallowed; each dose contains 20 mg of cannabidiol per kilogram of body weight. Cannabidiol is a well‑studied plant compound that is already approved for certain seizure disorders and is widely described in medical literature, though it does not have an ATC code for this use. The trial is testing it for recurrent pericarditis, a condition where the heart’s lining becomes inflamed repeatedly. It works by gently influencing the body’s endocannabinoid system, especially the CB1 and CB2 receptors, which helps reduce inflammation and calm the immune response, and it is classified as a phytocannabinoid with anti‑inflammatory properties.

Investigated diseases

Recurrent pericarditis - Recurrent pericarditis is a condition where the lining around the heart becomes inflamed repeatedly. Each episode typically causes sharp chest pain that worsens when breathing or lying down. The inflammation may cause fluid to collect in the pericardial space, leading to a feeling of pressure. Symptoms usually improve with rest but can return weeks or months after an initial episode. Over time, repeated attacks can cause the pericardium to become thicker and less flexible. The disease pattern is marked by cycles of flare‑ups followed by periods of fewer or no symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-507452-77-00Protocol codeCardiol 100-004Estimated enrolment25 patientsSponsorCardiol Therapeutics Inc.

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