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Taking people in JapanPhase 3

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial
Record updated
10 July 2026