Heart failure & cardiomyopathies
Impact of Cannabidiol on Myocardial Recovery in Patients with Acute Myocarditis: Rationale & Design of the ARCHER Trial
Authors' conclusion
The ongoing ARCHER Trial is an international, multicentre, double-blind, randomized, placebo-controlled phase II study, designed to determine the effect of a pharmaceutically produced cannabidiol formulation on CMR parameters in patients presenting with acute myocarditis.
Study context
- Population
- Patients with mild to moderate acute myocarditis, randomised within 10 days of diagnostic cardiac MRI (CMR)planned
- Participants
- 100 patients
- Comparison
- Cannabidiol vs placebo
- Primary endpoint
- Change in global longitudinal strain (GLS) and extracellular volume (extra cellular volume (ECV)) by CMR
- Follow-up
- 12 weeks
Methodological detailsARCHER, international, multicentre, double-blind, placebo-controlled, phase II, Secondary endpoint: change in left ventricular ejection fraction (LVEF) from baseline to week 12, Enrolment expected to conclude Q3 2024; results early 2025, Sample size: 80% power, 5% alpha, 25% missing CMR data at week 12, treatment effect 18%, Exploratory: hs-troponin, NT-proBNP, inflammation and endothelial function markers
- ARCHER
- International
- Multicentre
- Double-blind
- Placebo-controlled
- Phase II
- Secondary endpoint: change in LVEF from baseline to week 12
- Enrolment expected to conclude Q3 2024; results early 2025
- Sample size: 80% power, 5% alpha, 25% missing CMR data at week 12, treatment effect 18%
- Exploratory: hs-troponin, NT-proBNP, inflammation and endothelial function markers
Primary result
As reported in the abstract
- No interim data available; trial ongoing
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Impact of Cannabidiol on Myocardial Recovery in Patients with Acute Myocarditis: Rationale & Design of the ARCHER Trial. ESC Heart Fail. Published 27 June 2024. doi:10.
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