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Cardiac Sarcoidosis Randomized Trial

Study acronym: CHASM-CS-RCT
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Enrollment reduced: 194 → 160 participantsv15
  2. Study sites: 30 to 31v14
  3. Primary and study completion dates: Dec 2025 to Dec 2026
    • Site contacts updated at 30 of 30 sites
    v13
  4. Site details revised at 1 of 30 sitesv12
  5. Study sites: 31 to 30
    • Eligibility criteria expanded, about 7 words
    • Study description expanded, about 6 words
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: Dec 2023 to Dec 2025
    • Study sites: 18 to 31
    • Study completion date: Dec 2024 to Dec 2025
    • Eligibility criteria expanded, about 6 words
    v10
  2. Study sites: 17 to 18
    • Interventions: Methotrexate (Drug), Prednisone (Drug) to Methotrexate (Drug), Prednisone or Prednisolone (Drug)
    • Study description expanded, about 63 words
    v9
  3. Study sites: 14 to 17v8
  4. Site details revised at 2 of 14 sitesv7
  5. Primary completion date: Dec 2022 to Dec 2023
    • Study completion date: Dec 2023 to Dec 2024
    • Site details revised at 1 of 14 sites
    • Study description expanded, about 4 words
    v6
  6. Study sites: 8 to 14v5
  7. Study sites: 7 to 8v4
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2018 to Jan 15, 2019
    • Site details revised at 7 of 7 sites
    v3
  9. Start date: Sep 2018 to Dec 2018v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT03593759
Lead Sponsor Ottawa Heart Institute Research Corporation
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions
(from sponsor)		 Cardiac Sarcoidosis, Sarcoidosis
Related terms Sarcoidosis
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov