🔎 Trials Near Me

Home › Sarcoidosis › NCT03593759

Cardiac Sarcoidosis Randomized Trial

RecruitingPhase 3

Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial

Who can join

Ages 18 and older · All sexes

Full eligibility 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

About the study

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).

What is being tested

Sponsor: Ottawa Heart Institute Research Corporation · Participants: 160 · Started: Jan 15, 2019

Contact the study team

Official record on ClinicalTrials.gov — NCT03593759

Locations in the U.S.

ConnecticutYale-New Haven Hospital, New Haven
MassachusettsTufts Medical Center, Boston
MichiganUniversity of Michigan-Michigan Medicine Cardiovascular Center, Ann Arbor
MinnesotaUniversity of Minnesota, Minneota (Not yet recruiting)
New YorkMontefiore Medical Center, New York
OhioThe Ohio State University Wexner Medical Center, Columbus
PennsylvaniaAllegheny General Hospital, Pittsburgh
UtahUniversity of Utah, Salt Lake City
VirginiaVirginia Commonwealth University, Richmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.