Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
194 participants
INTERVENTIONAL
2019-01-15
2025-12-31
Brief Summary
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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).
Detailed Description
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Everywhere but Japan:
1. Prednisone 0.5 mg kg/day for 6-months (MAX dose 30 mg per day) or
2. Methotrexate 15-20 mg po, sc, or IM once a week for 6-months + Folic Acid OD (exact dose and directions at physician) for 6 months + Prednisone 20 mg day for 1 month, then 10 mg OD for 1 month, then 5 mg OD for one month then STOP
In Japan:
1. Prednisone or prednisolone 0.5 mg/kg po (max 30mg) for one month then reduce by 5 mg per month for five months or
2. Methotrexate 5-20mg po, sc or IM once week for 6-months +Folic Acid 2-5 mg OD for 6-months+Prednisone or prednisolone 20mg OD for 1 month then 10mg OD for 1 month then 5 mg OD one month
Methotrexate will be initiated at a dose of 15 mg once a week and increased to 20 mg once a week after 4 weeks if tolerated. In case of Methotrexate-induced side-effects general guidelines will be provided, however specific management will be left to the treating physicians. Folic acid will be taken to help reduce methotrexate side-effects.
Prior to randomization and study treatment all subjects will have the following baseline tests done: baseline safety blood work; FDG-PET scan with myocardial perfusion imaging; ECG; echo; and an optional bone mineral density scan. Cardiac MRI (CMR) is optional but strongly encouraged. Blood will be obtained for biomarker core-lab analysis. Biomarkers to be assayed will include highly sensitive Troponin I. Samples will be stored for future novel biomarker discovery. Quality of LIfe (QOL) questionnaires (KSQ, SAT and SF-36) will be completed prior to treatment start.
After therapy initiation subjects will be seen at 4 weeks, 8 weeks (methotrexate arm only), and 12 weeks, with a final visit at 6 months. Safety bloodwork and assessment for medication side effects, using a medication side-effect questionnaire, will be completed at all visits. At 12 weeks QOL questionnaires will be completed. The primary endpoint will be assessed at 6-months, when FDG-PET with myocardial perfusion imaging, ECG, echo, optional bone mineral density scan, QOL questionnaires, blood for biomarkers and device interrogation will be done. CMR may be repeated. Skin, muscle strength testing and neuropsychiatric assessment will be completed at 6 months as part of the composite glucocorticoid toxicity index.
After the 6 month visit. further management will be at the treating physician's discretion. Details of the physicians planned treatment following the 6-month PET scan will be collected.
Standardized protocols for all aspects of FDG-PET scans (i.e. patient preparation, image acquisition, image processing, transfer to the core lab and analysis at core lab) will be followed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prednisone (or Prednisolone)
\[Dose everywhere except Japan\] Prednisone 0.5 mg kg/day for 6 months (max dose 30 mg)
\[Dose in Japan\] Prednisone or prednisolone 0.5 mg/kg po (max 30mg) for one month then reduce by 5 mg per month for five months
Prednisone or Prednisolone
Oral prednisone/prednisolone tablet
Methotrexate
\[Dose everywhere except Japan\] Methotrexate 15-20 mg orally, sc, or IM once a week for 6 months + Prednisone 20 mg po daily for one month then 10 mg po daily for one month then 5 mg po daily for one month and then stop. Also Folic Acid OD (exact dose and directions at physicians discretion) for 6 months.
\[Dose in Japan\] Methotrexate 5-20mg mg orally, sc, or IM once a week for 6 months+ Prednisone or Prednisolone 20mg OD for 1 month then 10mg OD for 1 month then 5 mg OD one month. Also Folic Acid 2 mg po daily for 6 months.
Prednisone or Prednisolone
Oral prednisone/prednisolone tablet
Methotrexate
Oral, subcutaneous, or intramuscular methotrexate
Interventions
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Prednisone or Prednisolone
Oral prednisone/prednisolone tablet
Methotrexate
Oral, subcutaneous, or intramuscular methotrexate
Eligibility Criteria
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Inclusion Criteria
* 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%)
AND
(ii) No alternative explanation for clinical features
AND
(iii) Nuclear Imaging within six-months of enrollment 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
6. Patient is unable or unwilling to provide informed consent
7. Patient is included in another randomized clinical trial
8. Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia
9. Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment)
10. Breastfeeding
11. Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study
12. Patients for whom the investigator believes that the trial is not in the interest of the patient
Exclusion Criteria
2. Current Oral/IV treatment of duration greater than 5 days
3. Currently taking Methotrexate or Prednisone for another health condition
4. Intolerance or contra-indication to Methotrexate or Prednisone
18 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Ottawa Heart Institute Research Corporation
OTHER
Responsible Party
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Principal Investigators
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David H Birnie, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
Locations
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Yale-New Haven Hospital
New Haven, Connecticut, United States
Tufts Medical Center
Boston, Massachusetts, United States
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
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Libin Cardiovascular Institute of Alberta
Calgary, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Eastern Health Health Sciences Centre
St. John's, Newfoundland and Labrador, Canada
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada
St. Joseph's Healthcare Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
CIUSSS-Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
Québec, Quebec, Canada
CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, Canada
Hokkaido University
Sapporo, Kita 8, Nishi 5, Kita-Ku, Japan
Chiba University
Chiba, , Japan
University of Fukui
Fukui, , Japan
St. Marrianna University
Kawasaki, , Japan
Nagoya City University
Nagoya, , Japan
National Cerebral and Cardiovascular Center (NCVC)
Osaka, , Japan
Sapporo Medical University
Sapporo, , Japan
Nippon Medical School
Tokyo, , Japan
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare Trust-NHS-Hammersmith Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Edward Miller, MD
Role: backup
Mili Mehta, MD
Role: primary
Amanda Vest, MD
Role: backup
Todd Koelling, MD
Role: backup
C Shenoy, MD
Role: primary
Yogita Rochlani, MD
Role: backup
Steven Kalbfleisch, MD
Role: backup
Indu Poornima, MD
Role: backup
Line Kemeyou, MD
Role: backup
Jordana Kron, MD
Role: backup
Russell Quinn, MD
Role: backup
Mustafa Toma, MD
Role: backup
Stephen Duffett, MD
Role: backup
Doug Hayami, MD
Role: backup
Nathan Hambly, MD
Role: backup
Nikolaos Tzemos, MD
Role: backup
David Birnie, MD
Role: backup
Genevieve Giraldeau, MD
Role: backup
Leila Laroussi, MD
Role: backup
Mario Senechal, MD
Role: backup
Felix Ayala-Paredes, MD
Role: backup
Toshiyuki Nagai, MD
Role: backup
Y Koboyashi, MD
Role: primary
Y Koboyashi
Role: backup
H Tada, MD
Role: primary
Y. Akashi, MD
Role: primary
Y Akashi, MD
Role: backup
K Nakasuka, MD
Role: backup
Kengo Kusano, MD
Role: backup
Toshiyuki Yano, MD
Role: backup
Kenji Yodagawa, MD
Role: backup
Francis D Murgatroyd, MD
Role: backup
Amanda Varnava, MD
Role: backup
References
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Birnie D, Beanlands RSB, Nery P, Aaron SD, Culver DA, DeKemp RA, Gula L, Ha A, Healey JS, Inoue Y, Judson MA, Juneau D, Kusano K, Quinn R, Rivard L, Toma M, Varnava A, Wells G, Wickremasinghe M, Kron J. Cardiac Sarcoidosis multi-center randomized controlled trial (CHASM CS- RCT). Am Heart J. 2020 Feb;220:246-252. doi: 10.1016/j.ahj.2019.10.003. Epub 2019 Oct 20.
Other Identifiers
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UOttawaHI
Identifier Type: -
Identifier Source: org_study_id