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NCT05180240 · ClinicalTrials.gov registry record · Phase 2

Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis

A Phase 2 study, sponsored by Cardiol Therapeutics.

Completed
Registry status
Phase 2
Development phase
109
Enrollment target

NCT05180240: Completed Phase 2 study, sponsored by Cardiol Therapeutics.

NCT05180240 is a Phase 2 study that has completed, run by Cardiol Therapeutics. The registered enrollment target is 109 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05180240, a Phase 2 study, has completed, sponsored by Cardiol Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
109 participants
Enrollment target

Study Summary

Multi-center, double-blind, placebo-controlled, parallel group design. Patients with myocarditis will be screened and, if eligible, randomized within 10 days of the diagnostic CMR to CardiolRx or placebo. CardiolRx is pharmaceutically produced Cannabidiol and is free of tetrahydrocannabinol (THC\<5 ppm). The treatment period is 12 weeks; a last follow-up visit is scheduled one week after the last treatment, 13 weeks after randomization. Study assessments include Cardiac Magnetic Resonance imaging (CMR), ECG monitoring, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as physical exams and laboratory tests. The primary and secondary outcome parameters are measured by CMR. Additional outcomes include clinical endpoints and changes in inflammatory and biomarkers.

Primary Outcome

Change of ECV from baseline at 12 weeks, measured by cardiac Cardiac MRI. ECV is measuring the degree of edema and fibrosis. The unit of measure was percentage. It was the percentage of myocardial tissue that is extracellular space (i.e. fraction of the myocardium occupied by extracellular matrix and interstitial fluid).

Interventions

  • DRUG CardiolRx

Trial Details

FieldValue
Enrollment Target 109 participants
Start Date 2022-07-28
Est. Completion 2025-02-04
Phase Phase 2
Cardiol Therapeutics

4 total trials

What the finished NCT05180240 record still lists

NCT05180240 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower).

The record links to 0 conditions, and to 1 intervention - of which CardiolRx is the first listed.

NCT05180240 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05180240 about?

NCT05180240 is a clinical study titled "Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis". Multi-center, double-blind, placebo-controlled, parallel group design. Patients with myocarditis will be screened and, if eligible, randomized within 10 days of the diagnostic CMR to CardiolRx or placebo. CardiolRx is pharmaceutically produced Cannabidiol and is free of tetrahydrocannabinol (THC\<5...

What is the current status of trial NCT05180240?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2022-07-28. Estimated completion is 2025-02-04.

What interventions are being tested in trial NCT05180240?

The interventions under investigation include: CardiolRx (DRUG).

Who is sponsoring clinical trial NCT05180240?

This trial is sponsored by Cardiol Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05180240's enrollment target sits among peer trials

109 640th of 2000 higher than 1,361 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05180240, the US trial registry maintained by the National Library of Medicine. NCT05180240 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.