Health TrialsbyHealthPanel

Cardiac Sarcoidosis Randomized Trial

ConditionsCardiac SarcoidosisSarcoidosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%)

Disqualifiers

Current or recent (within two months) non-topical treatment for sarcoidosis

Current Oral/IV treatment of duration greater than 5 days

Currently taking Methotrexate or Prednisone for another health condition

Intolerance or contra-indication to Methotrexate or Prednisone

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prednisone or Prednisolone

    Drug

    Oral prednisone/prednisolone tablet

  • Methotrexate

    Drug

    Oral, subcutaneous, or intramuscular methotrexate

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Prednisone (or Prednisolone)Active comparator 1 intervention
Group B: MethotrexateExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Summed perfusion rest score (SPRS) on FDG-PET scan

Measure of myocardial scarring and fibrosis (blinded core lab analysis)

Time frame
6 months

Secondary outcomes

1

Mortality

All cause deaths

Time frame
6 months
2

Cardiovascular hospitalizations

Cardiovascular related only

Time frame
6 months
3

Medication related adverse events

Using clinical assessment, medication side-effect and adverse event reporting

Time frame
6 months
4

Modified Cleveland Clinic Glucocorticoid Toxicity Score

Summed score of new/worsening diabetes;new/worsening HTN; osteoporosis; change in height and weight (combined and reported as BMI in kg/m2)

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Heart Institute Research Corporation

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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