Cardiac Sarcoidosis Randomized Trial
Key facts
- Who runs it
- Ottawa Heart Institute Research Corporation
- Where
- Chiba, Fukui, Kawasaki, Nagoya, Osaka, Sapporo, and Tokyo, JapanSee the 8 sitesAlso in 4 other countries, 23 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 160 people, planned
- Started
- 15 Jan 2019
- Expected to end
- Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Prednisone or Prednisolone
- Methotrexate
- Record updated
- 10 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- (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%); 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
Who cannot take part
- Currently taking Methotrexate or Prednisone for another health condition
- Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment)
- Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study
- Current or recent (within two months) non-topical treatment for sarcoidosis
- Current Oral/IV treatment of duration greater than 5 days
- Intolerance or contra-indication to Methotrexate or Prednisone
- Patient does not meet all of the above listed inclusion criteria
- Patient is unable or unwilling to provide informed consent
- Patient is included in another randomized clinical trial
- Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia
- Breastfeeding
- Patients for whom the investigator believes that the trial is not in the interest of the patient
Where in Japan
Also in 4 other countries, 23 sites
- Chiba UniversityChiba, JapanContact: Y Koboyashi, MDTaking people
- University of FukuiFukui, JapanContact: H Tada, MDNot yet recruiting
- St. Marrianna UniversityKawasaki, JapanContact: Y. Akashi, MDNot yet recruiting
- Nagoya City UniversityNagoya, JapanContact: K Nakasuka, MDTaking people
- National Cerebral and Cardiovascular Center (NCVC)Osaka, JapanContact: Kengo Kusano, MDTaking people
- Hokkaido UniversitySapporo, JapanContact: Toshiyuki Nagai, MDTaking people
- Sapporo Medical UniversitySapporo, JapanContact: Toshiyuki Yano, MDTaking people
- Nippon Medical SchoolTokyo, JapanContact: Kenji Yodogawa, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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).
The 2 groups in the trial
- Prednisone (or Prednisolone)Existing treatment, for comparison
\[Dose everywhere except Japan\] 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
- MethotrexateTreatment being tested
\[Dose everywhere except Japan\] 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.
Treatment: Prednisone or Prednisolone and Methotrexate
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial
- Record updated
- 10 July 2026