RECRUITING

Cardiac Sarcoidosis Randomized Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial

Quick Facts

Study Start:2019-01-15
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03593759

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * advanced conduction system disease (defined as Mobitz II AV block or third degree AV block)
  2. * significant sinus node dysfunction (defined as average HR less than 40bpm when awake and/or sustained atrial arrhythmias)
  3. * non- sustained or sustained ventricular arrhythmia
  4. * left ventricular dysfunction (LVEF \< 50%)
  5. * right ventricular dysfunction (RVEF \< 40%)
  1. 1. Current or recent (within two months) non-topical treatment for sarcoidosis
  2. 2. Current Oral/IV treatment of duration greater than 5 days
  3. 3. Currently taking Methotrexate or Prednisone for another health condition
  4. 4. Intolerance or contra-indication to Methotrexate or Prednisone
  5. 5. Patient does not meet all of the above listed inclusion criteria
  6. 6. Patient is unable or unwilling to provide informed consent
  7. 7. Patient is included in another randomized clinical trial
  8. 8. Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia
  9. 9. Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment)
  10. 10. Breastfeeding
  11. 11. Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study
  12. 12. Patients for whom the investigator believes that the trial is not in the interest of the patient

Contacts and Locations

Study Contact

David H Birnie, MD
CONTACT
613-696-7269
dbirnie@ottawaheart.ca
Janine Ryan, BAH, CCRP
CONTACT
613-696-7000
jryan@ottawaheart.ca

Principal Investigator

David H Birnie, MD
PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation

Study Locations (Sites)

Yale-New Haven Hospital
New Haven, Connecticut, 06520
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
University of Michigan-Michigan Medicine Cardiovascular Center
Ann Arbor, Michigan, 48109-5853
United States
University of Minnesota
Minnesota, Minnesota, 55455
United States
Montefiore Medical Center
New York, New York, 10467
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
University of Utah
Salt Lake City, Utah, 84112
United States
Virginia Commonwealth University
Richmond, Virginia, 23298-0053
United States

Collaborators and Investigators

Sponsor: Ottawa Heart Institute Research Corporation

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-15
Study Completion Date2025-12

Study Record Updates

Study Start Date2019-01-15
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Cardiac Sarcoidosis
  • Prednisone (or Prednisolone)
  • Methotrexate

Additional Relevant MeSH Terms

  • Cardiac Sarcoidosis
  • Sarcoidosis