Cardiac Sarcoidosis Randomized Trial
CHASM-CS-RCT
Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial
1 other identifier
interventional
194
4 countries
30
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2019
Longer than P75 for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2018
CompletedFirst Posted
Study publicly available on registry
July 20, 2018
CompletedStudy Start
First participant enrolled
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 5, 2026
April 1, 2026
7.9 years
June 27, 2018
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Summed perfusion rest score (SPRS) on FDG-PET scan
Measure of myocardial scarring and fibrosis (blinded core lab analysis)
6 months
Secondary Outcomes (19)
Mortality
6 months
Cardiovascular hospitalizations
6 months
Medication related adverse events
6 months
Modified Cleveland Clinic Glucocorticoid Toxicity Score
6 months
Glucocorticoid Toxicity Index
6 months
- +14 more secondary outcomes
Study Arms (2)
Prednisone (or Prednisolone)
ACTIVE COMPARATOR\[Dose everywhere except Japan\] Prednisone 0.5 mg kg/day for 6 months (max dose 30 mg) \[Dose in Japan\] Prednisone or prednisolone 0.5 mg/kg po (max 30mg) for one month then reduce by 5 mg per month for five months
Methotrexate
EXPERIMENTAL\[Dose everywhere except Japan\] Methotrexate 15-20 mg orally, sc, or IM once a week for 6 months + Prednisone 20 mg po daily for one month then 10 mg po daily for one month then 5 mg po daily for one month and then stop. Also Folic Acid OD (exact dose and directions at physicians discretion) for 6 months. \[Dose in Japan\] Methotrexate 5-20mg mg orally, sc, or IM once a week for 6 months+ Prednisone or Prednisolone 20mg OD for 1 month then 10mg OD for 1 month then 5 mg OD one month. Also Folic Acid 2 mg po daily for 6 months.
Interventions
Oral prednisone/prednisolone tablet
Eligibility Criteria
You may qualify if:
- (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
You may not qualify if:
- 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
- Patient is unable or unwilling to provide informed consent
- Patient is included in another randomized clinical trial
- Patient has a contraindication to PET imaging or is unlikely to tolerate due to severe claustrophobia
- Pregnancy (all women of child bearing age and potential will have a negative BHCG test before enrollment)
- Breastfeeding
- Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study
- Patients for whom the investigator believes that the trial is not in the interest of the patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Yale-New Haven Hospital
New Haven, Connecticut, 06520, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
University of Michigan-Michigan Medicine Cardiovascular Center
Ann Arbor, Michigan, 48109-5853, United States
University of Minnesota
Minneota, Minnesota, 55455, United States
Montefiore Medical Center
New York, New York, 10467, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Virginia Commonwealth University
Richmond, Virginia, 23298-0053, United States
Libin Cardiovascular Institute of Alberta
Calgary, Alberta, T2N 2T9, Canada
St. Paul's Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Eastern Health Health Sciences Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
QE II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
St. Joseph's Healthcare Centre
Hamilton, Ontario, L8N 4A6, Canada
London Health Sciences Centre
London, Ontario, N6A 4A5, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
CIUSSS-Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5, Canada
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
Québec, Quebec, G1V 4G5, Canada
CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
Hokkaido University
Sapporo, Kita 8, Nishi 5, Kita-Ku, 060-0808, Japan
Chiba University
Chiba, Japan
University of Fukui
Fukui, Japan
St. Marrianna University
Kawasaki, Japan
Nagoya City University
Nagoya, Japan
National Cerebral and Cardiovascular Center (NCVC)
Osaka, Japan
Sapporo Medical University
Sapporo, Japan
Nippon Medical School
Tokyo, Japan
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
Imperial College Healthcare Trust-NHS-Hammersmith Hospital
London, W12 0HS, United Kingdom
Related Publications (1)
Birnie D, Beanlands RSB, Nery P, Aaron SD, Culver DA, DeKemp RA, Gula L, Ha A, Healey JS, Inoue Y, Judson MA, Juneau D, Kusano K, Quinn R, Rivard L, Toma M, Varnava A, Wells G, Wickremasinghe M, Kron J. Cardiac Sarcoidosis multi-center randomized controlled trial (CHASM CS- RCT). Am Heart J. 2020 Feb;220:246-252. doi: 10.1016/j.ahj.2019.10.003. Epub 2019 Oct 20.
PMID: 31911261DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David H Birnie, MD
Ottawa Heart Institute Research Corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2018
First Posted
July 20, 2018
Study Start
January 15, 2019
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share