Cardiac Sarcoidosis Randomized Trial

Description

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).

Conditions

Cardiac Sarcoidosis, Sarcoidosis

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Study Overview

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Study Details

Study overview

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).

Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial

Cardiac Sarcoidosis Randomized Trial

Condition
Cardiac Sarcoidosis
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale-New Haven Hospital, New Haven, Connecticut, United States, 06520

Boston

Tufts Medical Center, Boston, Massachusetts, United States, 02111

Ann Arbor

University of Michigan-Michigan Medicine Cardiovascular Center, Ann Arbor, Michigan, United States, 48109-5853

Minnesota

University of Minnesota, Minnesota, Minnesota, United States, 55455

New York

Montefiore Medical Center, New York, New York, United States, 10467

Columbus

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

Pittsburgh

Allegheny General Hospital, Pittsburgh, Pennsylvania, United States, 15212

Salt Lake City

University of Utah, Salt Lake City, Utah, United States, 84112

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23298-0053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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%)
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ottawa Heart Institute Research Corporation,

David H Birnie, MD, PRINCIPAL_INVESTIGATOR, Ottawa Heart Institute Research Corporation

Study Record Dates

2025-12