Study of Cannabidiol for Treatment of Recurrent Pericarditis in Affected Patients

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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).

Where you can join this trial?

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Other Sites

Site Name	City	Country
Hopital Beaujon	Clichy	France
Hdfzrcdo Uhdkyrfuogbwql Pjgfs Sixdyfenaom	Paris	France
Cbvora Hnoinkceedn Uxlvxotufiqyj Do Ctll Nnmrumwmb	Caen	France
Coikor Hmkipharfby Uonlhxtcaqlqx Da Pnmxwtzm	Poitiers	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.01.2024

Trial locations

Investigated Drugs:

Cannabidiol

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.

Investigated Diseases:

Pericarditis

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 ID:

2023-507452-77-00

Protocol code:

Cardiol 100-004

NCT ID:

NCT05494788

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Cannabidiol for Treatment of Recurrent Pericarditis in Affected Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?