CBD drug shows promise for stubborn heart pain
NCT ID NCT05494788
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a pure cannabidiol (CBD) solution called CardiolRx in 27 adults with recurrent pericarditis, a condition causing repeated inflammation and pain around the heart. Participants had not responded well to standard treatments or needed long-term steroids. The goal was to see if CardiolRx is safe and can help reduce pain and inflammation, and possibly allow patients to stop other medications. It was a small pilot study, so results are preliminary.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CardiolRx (pharmaceutically produced cannabidiol, a CBD oral solution)
- What this could lead to
- If this works, it could offer a new option to reduce pain and inflammation for people with recurrent pericarditis who don't respond to standard treatments.
- What could go wrong
- This is a small, early pilot study with only 27 participants, so results may not apply widely. It tested safety and symptom changes, not long-term effectiveness.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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27 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Sep 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Male or female 18 years of age or older 2. Diagnosis of at least two episodes of recurrent pericarditis\*, 3. At least 1 day with pericarditis pain ≥4 on the 11-point Numerical Rating Scale (NRS) within prior 7 days 4. One of; 1. C-Reactive Protein\*\* (CRP) level ≥1.0 mg/dL within prior 7 days OR 2. Evidence of pericardial inflammation assessed by delayed pericardial hyperenhancement on cardiac magnetic resonance imaging (CMR) 5. Currently receiving non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine and/or corticosteroids (in any combination) for treatment of pericarditis in stable doses 6. Male patients 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. 7. 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 postmenopausal (at least 1 y absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone \[FSH\] ≥40 mIU/mL \[or ≥ 40 IU/L\] if less than 2 y postmenopausal) or be surgically sterile. * Diagnosis of pericarditis according to the 2015 European Society of Cardiology (ESC) Guidelines for the Diagnosis and Management of Pericardial Diseases (Adler et al. 2015): At least two of: 1. Pericarditic chest pain 2. Pericardial rub 3. New widespread ST-segment elevation or PR-segment depression according to electrocardiogram (ECG) findings 4. Pericardial effusion (new or worsening) * Conversion: 1 mg/dL CRP = 10 mg/L hs-CRP Exclusion Criteria: 1. Diagnosis of pericarditis that is secondary to specific prohibited etiologies, including tuberculosis (TB); neoplastic, purulent, or radiation etiologies; post-thoracic blunt trauma (e.g., motor vehicle accident); myocarditis 2. Estimated glomerular filtration rate (eGFR) \<30 mL/min at screening 3. 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 4. Sepsis, defined as documented bacteremia at the time of screening or other documented active infection 5. Prior history of sustained ventricular arrhythmia 6. History of QT interval prolongation 7. QTc interval \> 500 msec 8. Current participation in any research study involving investigational drugs or device 9. Inability or unwillingness to give informed consent 10. Ongoing drug or alcohol abuse 11. On any cannabinoid during the past month 12. Women who are pregnant or breastfeeding 13. Current diagnosis of cancer, with the exception of non-melanoma skin cancer 14. Any factor, which would make it unlikely that the patient can comply with the study procedures 15. Showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS), administered at screening 16. On digoxin and/or type 1 or 3 antiarrhythmics 17. On immunosuppressive therapy with any of the following: 1. Rilonacept 2. Anakinra 3. Canakinumab 4. Methotrexate 5. Azathioprine 6. Cyclosporine 7. Intravenous immune globulin (IVIG)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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MedStar Health Research Institute
Washington D.C., District of Columbia, 20010, United States
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Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
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Pima Heart and Vascular Clinical Research
Tucson, Arizona, 85719, United States
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University of Vermont Medical Center
Burlington, Vermont, 05401, United States
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Virginia Commonwealth University Health
Richmond, Virginia, 23298, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 500 patients join study to unravel recurrent heart inflammation
- New study aims to predict which patients will get pericarditis again
- New shot aims to keep pericarditis Flare-Ups at bay
- New hope for heart lining pain: can CardiolRx keep flare-ups away?
- New shot aims to stop repeat heart sac inflammation
- New hope for heart inflammation sufferers: experimental drug VTX2735 enters Mid-Stage trial