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Clinical Trials in Japan / NCT03593759
Recruiting Phase 3

Cardiac Sarcoidosis Randomized Trial

NCT03593759 · tracked via the Priya Life Science Japan tracker
Phase
Phase 3
Started
2019-01-15
Last updated
2026-07-10

Condition(s) studied

Cardiac SarcoidosisSarcoidosis

Investigational drug(s) / intervention(s)

Prednisone or PrednisoloneAll Prednisone trials (164) →All Prednisolone trials (70) →Methotrexate →

Prednisone or Prednisolone: Oral prednisone/prednisolone tablet

Methotrexate: Oral, subcutaneous, or intramuscular methotrexate

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: (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 Exclusion Criteria: 1. Current or recent (within two months) non-topical treatment for sarcoidosis 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 5. Patient does not meet all of the above listed inclusion criteria 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

Primary outcome measure(s)

Trial sites (31)

FacilityCityRegionStatus
Yale-New Haven Hospital New Haven Connecticut Recruiting
Tufts Medical Center Boston Massachusetts Recruiting
University of Michigan-Michigan Medicine Cardiovascular Center Ann Arbor Michigan Recruiting
University of Minnesota Minneota Minnesota Not Yet Recruiting
Montefiore Medical Center New York New York Recruiting
The Ohio State University Wexner Medical Center Columbus Ohio Recruiting
Allegheny General Hospital Pittsburgh Pennsylvania Recruiting
University of Utah Salt Lake City Utah Recruiting
Virginia Commonwealth University Richmond Virginia 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 Recruiting
Hokkaido University Sapporo Kita 8, Nishi 5, Kita-Ku Recruiting
Chiba University Chiba Japan Recruiting
University of Fukui Fukui Japan Not Yet Recruiting
St. Marrianna University Kawasaki Japan Not Yet Recruiting
Nagoya City University Nagoya Japan Recruiting
National Cerebral and Cardiovascular Center (NCVC) Osaka Japan Recruiting
Sapporo Medical University Sapporo Japan Recruiting
Nippon Medical School Tokyo Japan Recruiting
Auckland City Hospital Auckland Grafton Recruiting
King's College Hospital NHS Foundation Trust London United Kingdom Not Yet Recruiting
Imperial College Healthcare Trust-NHS-Hammersmith Hospital London United Kingdom Not Yet Recruiting

More Ottawa Heart Institute Research Corporation trials in Japan

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03593759 on ClinicalTrials.gov ↗ ← All trials in Japan