Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial
Ottawa Heart Institute Research Corporation
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).
Description
Subjects meeting the study inclusion/exclusion criteria will be randomized equally to receive either: 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 w…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 consisti…
Interventions
- DrugPrednisone or Prednisolone
Oral prednisone/prednisolone tablet
- DrugMethotrexate
Oral, subcutaneous, or intramuscular methotrexate
Locations (30)
- Yale-New Haven HospitalNew Haven, Connecticut
- Tufts Medical CenterBoston, Massachusetts
- University of Michigan-Michigan Medicine Cardiovascular CenterAnn Arbor, Michigan
- University of MinnesotaMinneota, Minnesota
- Montefiore Medical CenterNew York, New York
- The Ohio State University Wexner Medical CenterColumbus, Ohio