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

Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial

Phase 3 Interventional Ottawa Heart Institute Research Corporation · NCT03593759

This study is testing whether a low dose of Prednisone combined with Methotrexate can help people with cardiac sarcoidosis just as well as a standard dose of Prednisone, while also making them feel better and reducing side effects.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment194 (estimated)
Ages18 Years and up
SexAll
SponsorOttawa Heart Institute Research Corporation Academic / other
Drugs / interventionsMethotrexate, Prednisone
Locations30 sites (New Haven, Connecticut and 29 other locations)
Trial IDNCT03593759 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with acute active cardiac sarcoidosis who exhibit specific clinical findings such as advanced conduction system disease or significant ventricular dysfunction.

Not a fit: Patients with alternative explanations for their clinical features or those currently receiving treatment for sarcoidosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a safer and more effective treatment option for patients with cardiac sarcoidosis.

How similar studies have performed: Other studies have explored similar treatment combinations for sarcoidosis, but this specific approach is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

New Haven, Connecticut and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cardiac SarcoidosisSarcoidosisPrednisoneMethotrexate
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.