Comparing Prednisone or Prednisolone with Methotrexate for cardiac sarcoidosis
Official title: Cardiac Sarcoidosis Randomized Trial
Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial
- Phase 3
- 2 groups
- Sites in Calgary, Vancouver and 8 more cities
- Recruiting
Interventions
- Medication
Prednisone or Prednisolone
Oral prednisone/prednisolone tablet
- Medication
Methotrexate
Oral, subcutaneous, or intramuscular methotrexate
Canadian Sites (11)
11 of 11 recruiting
- Recruiting
Libin Cardiovascular Institute of Alberta
Calgary, Alberta
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia
- Recruiting
Eastern Health Health Sciences Centre
St. John's, Newfoundland and Labrador
- Recruiting
QE II Health Sciences Centre
Halifax, Nova Scotia
- Recruiting
St. Joseph's Healthcare Centre
Hamilton, Ontario
- Recruiting
London Health Sciences Centre
London, Ontario
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario
- Recruiting
Montreal Heart Institute
Montreal, Quebec
- Recruiting
CIUSSS-Hopital du Sacre-Coeur de Montreal
Montreal, Quebec
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
Québec, Quebec
- Recruiting
CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont
Sherbrooke, Quebec
Eligibility Criteria
See who this study is looking for23 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +(i) Cardiac sarcoidosis presenting with one or more of the following clinical findings:
- +advanced conduction system disease (defined as Mobitz II AV block or third degree AV block)
- +significant sinus node dysfunction (defined as average HR less than 40bpm when awake and/or sustained atrial arrhythmias)
- +non- sustained or sustained ventricular arrhythmia
- +left ventricular dysfunction (LVEF \< 50%)
- +right ventricular dysfunction (RVEF \< 40%)
- +(ii) No alternative explanation for clinical features
- +(iii) Nuclear Imaging within six-months of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → consisting of FDG-PET scan with FDG uptake suggestive of active CS and myocardial perfusion imaging
- +AND ONE OR BOTH OF FOLLOWING
- +(iv) Positive biopsy for Sarcoid (either EMB or extra-cardiac)
- +(v) CT Chest showing features consistent with pulmonary sarcoidosis and/or mediastinal and/or hilar lymphadenopathy
Exclusion
- −Current or recent (within two months) non-topical treatment for sarcoidosis
- −Current Oral/IV treatment of duration greater than 5 days
- −Currently taking Methotrexate or Prednisone for another health condition
- −Intolerance or contra-indication to Methotrexate or Prednisone
- −Patient does not meet all of the above listed inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →
- −Patient is unable or unwilling to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- −Patient is included in another randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → clinical trialInterventional studyA study where participants are given something to see what happens.Read more →
- −Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia
- −Patients for whom the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → believes that the trial is not in the interest of the patient
- −Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →)
- −Breastfeeding
- −Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Prednisone or Prednisolone.
Registry label: A: Prednisone (or Prednisolone)
Group B receives Methotrexate, together with one or more of: Prednisone or Prednisolone.
Registry label: B: Methotrexate
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 160 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: 6 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Summed perfusion rest score (SPRS) on FDG-PET scan — measured over 6 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03593759 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Prednisone or PrednisoloneDrug
Oral prednisone/prednisolone tablet
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About MethotrexateDrug
Oral, subcutaneous, or intramuscular methotrexate
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 6 months.
The study as a whole is currently expected to finish around 2026-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 160 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 13 locations, including: Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; St. John's, Newfoundland and Labrador, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada, and 7 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated. The Investigators hypothesize that low dose Prednisone(or Prednisolone)/Methotrexate combination will be as effective as standard dose Prednisone(or Prednisolone), and result in significantly better quality of life and less toxicity than standard dose Prednisone(or Prednisolone).
Other Sites (3)
University of Michigan-Michigan Medicine Cardiovascular Center
Ann Arbor, Michigan, United States
University of Minnesota
Minneota, Minnesota, United States
Montefiore Medical Center
New York, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.