Comparing low dose Prednisone and Methotrexate to standard dose Prednisone for cardiac sarcoidosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a prospective randomized controlled trial that aims to compare the effectiveness of a low dose combination of Prednisone (or Prednisolone) and Methotrexate against a standard dose of Prednisone (or Prednisolone) in patients diagnosed with acute active cardiac sarcoidosis. Participants will be randomized to receive either treatment for six months, with various monitoring and safety assessments conducted throughout the trial. The study hypothesizes that the combination therapy will provide similar efficacy while improving quality of life and reducing toxicity compared to the standard treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Yale-New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• Tufts Medical Center
  Boston, Massachusetts, United States Recruiting
• University of Michigan-Michigan Medicine Cardiovascular Center
  Ann Arbor, Michigan, United States Recruiting
• Montefiore Medical Center
  New York, New York, United States Recruiting
• The Ohio State University Wexner Medical Center
  Columbus, Ohio, United States Recruiting
• Allegheny General Hospital
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: David H Birnie, MD — Ottawa Heart Institute Research Corporation
• Study coordinator: David H Birnie, MD
• Email: dbirnie@ottawaheart.ca
• Phone: 613-696-7269

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.