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Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis (ARCHER)

Primary Purpose

Acute Myocarditis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CardiolRx
Sponsored by
Cardiol Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocarditis focused on measuring Pharmaceutically produced CBC, THC < 5ppm

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males and females aged between 18 and 75 years (inclusive)
  2. LVEF < 0.50
  3. Diagnosis consistent with acute myocarditis including:

    1. Clinical criteria (symptoms of chest pain, arrhythmia or shortness of breath, or history of viral-like illness), preferably followed by elevated troponin in the absence of hemodynamically significant CAD* (defined as a stenosis greater than 50% in a major epicardial coronary artery) within the previous 90 days PLUS
    2. CMR diagnosis: (Lake Louise Criterial) OR
    3. Endomyocardial biopsy showing either cellular inflammation and/or immunohistochemistry consistent with inflammation
  4. Male subjects 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.
  5. 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 post- menopausal

Exclusion Criteria:

  1. Coronary artery disease (CAD) defined as a stenosis greater than 50% in a major epicardial coronary artery
  2. Severe valvular heart disease
  3. Inability to safely undergo CMR including administration of gadolinium
  4. Estimated glomerular filtration rate (eGFR) < 30 ml/min
  5. 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.
  6. Sepsis, defined as documented bacteremia at the time of presentation or other documented active infection.
  7. Severe left ventricular (LV) dysfunction - requiring inotropic support, left ventricular assist device (LVAD) or other circulatory assist devices, or urgent need for transplantation
  8. Documented biopsy evidence of giant cell or eosinophilic myocarditis
  9. Acute coronary syndrome (ACS) within 30 days
  10. Percutaneous coronary intervention (PCI) within 30 days
  11. History of QT interval prolongation or QTc interval > 500 msec
  12. Treated with strong inducers CYP3A4 or CYP2C19
  13. Current participation in any research study involving investigational drugs or devices
  14. Inability or unwillingness to give informed consent
  15. Ongoing drug or alcohol abuse
  16. Women who are pregnant or breastfeeding
  17. Current diagnosis of cancer, with the exception of non-melanoma skin cancer
  18. Any factor, which would make it unlikely that the patient can comply with the study procedures.
  19. On any cannabinoid during the past month
  20. Body weight > 170 kg
  21. Showing suicidal tendency as per the C-SSRS, administered at screening

Sites / Locations

  • MedStar Heart and Vascular InstituteRecruiting
  • Palm Springs Community Health Centre
  • Massachusetts General Hospital siteRecruiting
  • Minneapolis Heart Institute FoundationRecruiting
  • Cleveland ClinicRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • Virginia Commonwealth UniversityRecruiting
  • Nupec-OrizontiRecruiting
  • PUC trialsRecruiting
  • Complexo Hospitalar de NiteróiRecruiting
  • Hospital Moinhos de VentoRecruiting
  • Hospital de Clínicas de Porto Alegre (HCPA)Recruiting
  • Hospital Nove de JulhoRecruiting
  • Hospital Felicio Rocho - Fundação Felice RossoRecruiting
  • Hospital Angelina CaronRecruiting
  • Hospital São LucasRecruiting
  • Instituto D´Or de Pesquisa e EnsinoRecruiting
  • Hospital Pró-CardíacoRecruiting
  • Hospital Regional de São JoséRecruiting
  • Irmandade da Santa Casa de Misericórdia de São PauloRecruiting
  • Instituto do Coração - InCorRecruiting
  • University of Alberta HospitalRecruiting
  • McGill University Health CentreRecruiting
  • Hopital Louis Pradel Hospices Civils de LyonRecruiting
  • CHU de MontpellierRecruiting
  • Centre Hospitalier Universitaire de NîmesRecruiting
  • Hôpital Lariboisière - Département de CardiologieRecruiting
  • Hopital Bichat Claude BernardRecruiting
  • Hôpital européen Georges-PompidouRecruiting
  • Institut de Cardiologie hopital Pitié SalpêtrièreRecruiting
  • Centre Hospitalier Universitaire de PoitiersRecruiting
  • Hôpital FochRecruiting
  • Chu RangueilRecruiting
  • Barzilai Medical CenterRecruiting
  • Shaare Zedek Medical CenterRecruiting
  • Beilinson Hospital, Rabin medical CenterRecruiting
  • Tel Aviv Sourasky Medical Center (Ichilov)Recruiting
  • Shamir Medical Center (Assaf Harofeh)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CardiolRx

Placebo

Arm Description

Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo

Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo

Outcomes

Primary Outcome Measures

extracellular volume (ECV)
primary
Global longitudinal Strain (GLS)
primary

Secondary Outcome Measures

Left-ventricular ejection fraction (LVEF)
secondary endpoint

Full Information

First Posted
September 25, 2021
Last Updated
October 19, 2023
Sponsor
Cardiol Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05180240
Brief Title
Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis
Acronym
ARCHER
Official Title
Impact of CardiolRx on Myocardial Recovery in Acute Myocarditis. A Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiol Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Rationale: Myocarditis is an acute inflammatory condition of the myocardium. Presentation of the disease may be fulminant and necessitate cardiac support, or even result in sudden cardiac death; milder cases are usually self-limiting but may progress to dilated cardiomyopathy with eventual end-stage heart failure. Other than treatments for associated heart failure there are no specific indicated treatments for myocarditis. CardiolRxTM (cannabidiol [CBD] solution), which is known to have anti-inflammatory properties, is being investigated to treat the underlying inflammatory process and thereby favorably modify acute myocarditis. The primary endpoints of the trial are cardiac magnetic resonance measures of left ventricular systolic function (ejection fraction and longitudinal strain) and myocardial edema (extra cellular volume) which have been shown to predict long term prognosis of patients with acute myocarditis. Multi-center, double-blind, randomized, placebo-controlled, parallel group design. 1:1 randomization; treatment will be stratified within sites. Patients diagnosed with acute myocarditis by a biopsy or a CMR will be screened within 10 days of the diagnostic CMR. Informed consent will be obtained at this point. For patients who have been diagnosed using an EMB, a CMR needs to be performed as well, which will be included in the informed consent form (ICF).Eligible patients will then be randomized within 10 days from the CMR assessment. Baseline assessments include the following: Clinical assessment, including vital signs, ECG, 24-hr Holter, chest x-ray; Hematology and blood chemistry, NYHA classification, C SSRS and KCCQ. Frozen plasma will be retained for central analysis of hs-troponin, NT-proBNP and inflammatory markers. Study treatment needs to be taken with food and will be initiated in the evening of Day 1, after all baseline assessments have been completed and the patient has been randomized. Oral administration is as follows: • Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo • Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo If the next higher dose after each study drug increase is not tolerated, the dose will be reduced to the previous tolerated dose. Every week (before the next dose increase) the patient will be re-evaluated. This includes ECG monitoring at approximately 5 hours post-morning dose (time of Tmax) to surveil for deleterious effects on ECG intervals (particularly the QTc interval) and rhythm. Drug titration will be dependent on investigator or designate interrogation of the ECGs and the absence of new, clinically significant abnormalities on those ECGs. Vital signs, concurrent medication and Adverse Events (AEs), including Serious Adverse Events (SAEs) will be recorded, blood chemistry including liver function tests, hematology as well as INR assessments will be carried out. Final efficacy assessments (including a second CMR) will take place after 12 weeks of study treatment. A final safety assessment will take place after 13 weeks, 1 week after completion of study treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocarditis
Keywords
Pharmaceutically produced CBC, THC < 5ppm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Multi-center, double-blind, randomized, placebo-controlled, parallel group design. 1:1 randomization
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Placebo will match active study drug in color, odor, taste and appearance to assure proper blinding.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CardiolRx
Arm Type
Experimental
Arm Description
Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo
Intervention Type
Drug
Intervention Name(s)
CardiolRx
Other Intervention Name(s)
Cannabidiol
Intervention Description
Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
Primary Outcome Measure Information:
Title
extracellular volume (ECV)
Description
primary
Time Frame
12 weeks post randomization
Title
Global longitudinal Strain (GLS)
Description
primary
Time Frame
12 weeks post randomization
Secondary Outcome Measure Information:
Title
Left-ventricular ejection fraction (LVEF)
Description
secondary endpoint
Time Frame
12 weeks post randomization
Other Pre-specified Outcome Measures:
Title
Percentage of patients recovered
Description
defined as LVEF ≥ 0.55 at 12 weeks of treatment
Time Frame
From baseline to 12 weeks of treatment
Title
Survival, free from major event
Description
Major event defined as cardiac transplant, left-ventricular assist device (LVAD), hospitalization for Heart failure (HF)
Time Frame
12 weeks post randomization
Title
Change in CMR parameters (%)
Description
Any change in CMR parameters from baseline to 12 weeks post randomization: LVEF (%), ECV (%), GLS (%), LGE (%)
Time Frame
From baseline to 12 weeks of treatment
Title
Change in CMR parameters (mL/m2)
Description
Any change in CMR parameters from baseline to 12 weeks post randomization: LVEDV (ml/m2), LVESV (ml/m2), LAESV (ml/m2).
Time Frame
From baseline to 12 weeks of treatment
Title
Change in CMR parameters (g/m2)
Description
Any change in CMR parameters from baseline to 12 weeks post randomization: LV mass (g/m2)
Time Frame
From baseline to 12 weeks of treatment
Title
New York Heart Association classification (NYHA)
Description
New York Heart Association classification (NYHA) ranked in order of best to worse outcome from Class I (best) to Class IV (worst). Record any change from baseline in percentage of patients in NYHA class IV/III/II class over the course of 12 weeks.
Time Frame
From baseline to 12 weeks of treatment
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
Any changes from baseline KCCQ compared to after 12 weeks of treatment Where "No limits" is the best outcome and "Severely limited" is the worst outcome.
Time Frame
From baseline to 12 weeks of treatment
Title
Time to resolution of clinical symptoms
Description
chest pain, arrhythmias, shortness of breath
Time Frame
From baseline to 12 weeks of treatment
Title
Changes in inflammatory and biomarker hs-troponin (nh/ml)
Description
Patients with myocarditis present with abnormal (very high) values in inflammatory and biomarkers. The investigators are trying to determine if CardiolRx normalizes them faster than placebo.
Time Frame
From baseline to 12 weeks of treatment
Title
Changes in inflammatory and biomarkers NT-proBNP (pg/ml), TNF-alpha (pg/ml), IL-1 beta (pg/ml) and IL-6 (pg/ml)
Description
Patients with myocarditis present with abnormal (very high) values in inflammatory and biomarkers. The investigators are trying to determine if CardiolRx normalizes them faster than placebo.
Time Frame
From baseline to 12 weeks of treatment
Title
Changes in inflammatory and biomarkers hs-CRP (mg/l), and ferritin (mg/l)
Description
Patients with myocarditis present with abnormal (very high) values in inflammatory and biomarkers. The investigators are trying to determine if CardiolRx normalizes them faster than placebo.
Time Frame
From baseline to 12 weeks of treatment
Title
Changes in inflammatory and biomarker IL-10 (ng/ml)
Description
Patients with myocarditis present with abnormal (very high) values in inflammatory and biomarkers. The investigators are trying to determine if CardiolRx normalizes them faster than placebo.
Time Frame
From baseline to 12 weeks of treatment
Title
Normalization of prognostically important ECG changes
Description
Time to normalization of normalization of PR interval
Time Frame
From baseline to 12 weeks of treatment
Title
Normalization of prognostically important ECG changes
Description
Time to normalization of normalization of QRS duration
Time Frame
From baseline to 12 weeks of treatment
Title
Normalization of prognostically important ECG changes
Description
Time to normalization of normalization of ST/T wave changes
Time Frame
From baseline to 12 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females 18 years of age or older Diagnosed with acute myocarditis including: Clinical criteria (symptoms of chest pain, arrhythmia or shortness of breath, or history of viral-like illness), preferably followed by elevated troponin PLUS CMR diagnosis (Lake Louise Criteria) within 10 days prior to randomization OR Endomyocardial biopsy (EMB) showing either cellular inflammation and/or immunohistochemistry consistent with inflammation. Male subjects 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. 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 post- menopausal. Exclusion Criteria: Coronary artery disease (CAD) defined as a stenosis greater than 50% in a major epicardial coronary artery Severe valvular heart disease Inability to safely undergo CMR including administration of gadolinium Estimated glomerular filtration rate (eGFR) < 30 ml/min 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. Sepsis, defined as documented bacteremia at the time of presentation or other documented active infection. Severe left ventricular (LV) dysfunction requiring inotropic support, left ventricular assist device (LVAD) or other circulatory assist devices, or urgent need for transplantation Documented biopsy evidence of giant cell or eosinophilic myocarditis Prior history of sustained ventricular arrhythmia Acute coronary syndrome within 30 days Percutaneous coronary intervention within 30 days History of QT interval prolongation or QTc interval > 500 msec Treated with strong inducers CYP3A4 or CYP2C19, as listed in Appendix 17.8 Treated with digoxin and/or type 1 or 3 antiarrhythmics Current participation in any research study involving investigational drugs or devices Inability or unwillingness to give informed consent Ongoing drug or alcohol abuse Women who are pregnant or breastfeeding Current diagnosis of cancer, with the exception of non-melanoma skin cancer Any factor, which would make it unlikely that the patient can comply with the study procedures On any cannabinoid during the past month Body weight > 170 kg Showing suicidal tendency as per the C-SSRS, administered at screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea B Parker, MSc, PhD
Phone
+1 289.910.0862
Email
andrea.parker@cardiolrx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Hamer, MD
Phone
+1 289.910.0380
Email
andrew.hamer@cardiolrx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis McNamara, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Chair
Facility Information:
Facility Name
MedStar Heart and Vascular Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Hofmeyer, Dr.
Email
Mark.Hofmeyer@Medstar.net
First Name & Middle Initial & Last Name & Degree
Mark Hofmeyer, Dr.
Facility Name
Palm Springs Community Health Centre
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Withdrawn
Facility Name
Massachusetts General Hospital site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Zlotoff, Dr.
Email
DZLOTOFF@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Daniel Zlotoff, Dr.
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Lin, MD
Email
David.Lin@allina.com
First Name & Middle Initial & Last Name & Degree
David Lin, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavan Bhat, Dr.
Email
bhatp@ccf.org
First Name & Middle Initial & Last Name & Degree
Pavan Bhat, Dr.
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Palmer, MD
Email
palmerba2@upmc.edu
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roshanak Markley, Dr.
Email
roshanak.markley@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
Roshanak Markley, Dr.
Facility Name
Nupec-Orizonti
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30210090
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Neuenschwander
Email
fcn2709@gmail.com
Facility Name
PUC trials
City
Curitiba
State/Province
PR
ZIP/Postal Code
80230-130
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LIdia Moura, MD
Facility Name
Complexo Hospitalar de Niterói
City
Niterói
State/Province
Rio De Janeiro
ZIP/Postal Code
24020-096
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurea Grippa, MD
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Dytz
Email
eduardo.almeida@hmv.org.br
Facility Name
Hospital de Clínicas de Porto Alegre (HCPA)
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Beck da Silva
Email
lbneto@hcpa.edu.br
Facility Name
Hospital Nove de Julho
City
São Paulo
State/Province
SP
ZIP/Postal Code
01409-002
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thais Pinheiro Lima, MD
Facility Name
Hospital Felicio Rocho - Fundação Felice Rosso
City
Belo Horizonte
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria da Consolação Vieira Moreira, MD
Facility Name
Hospital Angelina Caron
City
Campina Grande Do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalton Bertolim Precoma, MD
Email
daltonprecoma@gmail.com
Facility Name
Hospital São Lucas
City
Porto Alegre
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulo Avancini Caramori, MD
Email
caramori@cardiarte.com.br
Facility Name
Instituto D´Or de Pesquisa e Ensino
City
Rio de Janeiro
ZIP/Postal Code
22281-100
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denilson Campos de Albuquerque
Facility Name
Hospital Pró-Cardíaco
City
Rio de Janeiro
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelo Westerlund Montera, MD
First Name & Middle Initial & Last Name & Degree
Marcelo Westerlund Montera
Facility Name
Hospital Regional de São José
City
São José
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Artur Haddad Herdy, MD
Email
arherdy@cardiosport.com.br
Facility Name
Irmandade da Santa Casa de Misericórdia de São Paulo
City
São Paulo
ZIP/Postal Code
01223-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariane Vieira Scarlatelli Macedo
Facility Name
Instituto do Coração - InCor
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edimar Bocchi, MD
Email
dcledimar@incor.usp.br
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Ezekowitz, Dr.
Email
jae2@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Justin Ezekowitz, Dr.
Facility Name
McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Friedrich, Dr.
Email
matthias.friedrich@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Matthias Friedrich, Dr.
Facility Name
Hopital Louis Pradel Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Bochaton
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François ROUBILLE, MD
Facility Name
Centre Hospitalier Universitaire de Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit LATTUCA
Facility Name
Hôpital Lariboisière - Département de Cardiologie
City
Paris
ZIP/Postal Code
75475
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theo PEZEL, MD
Facility Name
Hopital Bichat Claude Bernard
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremie Abtan, MD
Facility Name
Hôpital européen Georges-Pompidou
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne Puymirat, MD
Facility Name
Institut de Cardiologie hopital Pitié Salpêtrière
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu Kerneis, MD
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire BOULETI, MD
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florent HUANG, MD
Facility Name
Chu Rangueil
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clément Delmas, MD
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Alejandro Piltz, Dr.
Email
piltzx@bmc.gov.il
First Name & Middle Initial & Last Name & Degree
Xavier Alejandro Piltz, Dr.
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Orlev
Email
amiror@szmc.org.il
First Name & Middle Initial & Last Name & Degree
Amir Orlev
Facility Name
Beilinson Hospital, Rabin medical Center
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alon Eisen, Prof.
Email
Alonei1@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Alon Eisen, Prof.
Facility Name
Tel Aviv Sourasky Medical Center (Ichilov)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaron Arbel, Prof.
Email
yarona@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Yaron Arbel, Prof.
Facility Name
Shamir Medical Center (Assaf Harofeh)
City
Zrifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gil Moravsky, Dr.
Email
gmoravsky@shamir.gov.il
First Name & Middle Initial & Last Name & Degree
Gil Moravsky, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26772776
Citation
Lee WS, Erdelyi K, Matyas C, Mukhopadhyay P, Varga ZV, Liaudet L, Hasku G, Cihakova D, Mechoulam R, Pacher P. Cannabidiol Limits T Cell-Mediated Chronic Autoimmune Myocarditis: Implications to Autoimmune Disorders and Organ Transplantation. Mol Med. 2016 Sep;22:136-146. doi: 10.2119/molmed.2016.00007. Epub 2016 Jan 8.
Results Reference
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Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis

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