Cardiac Sarcoidosis multi-center randomized controlled trial (CHASM CS- RCT).
David Birnie, Rob S B Beanlands, Pablo Nery...
https://pubmed.ncbi.nlm.nih.gov/31911261Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID03593759
Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial Comparing Low Dose Prednisone/Methotrexate Combination to Standard Dose Prednisone
Led by Ottawa Heart Institute Research Corporation · Updated on 2026-05-05
194
Participants Needed
30
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Ottawa Heart Institute Research Corporation
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatment options for patients diagnosed with acute active clinically manifest cardiac sarcoidosis who have not yet received treatment. This phase 3 randomized controlled trial compares low dose Prednisone (or Prednisolone) combined with Methotrexate to standard dose Prednisone (or Prednisolone). The study aims to determine if the combination therapy is as effective as the standard treatment while improving quality of life and reducing medication side effects. Participants will be randomly assigned to one of two treatment groups. Outside Japan, one group receives Prednisone 0.5 mg/kg daily for six months (maximum 30 mg per day), while the other group receives Methotrexate 15-20 mg once weekly plus Folic Acid daily for six months, combined with a tapering dose of Prednisone over three months. In Japan, dosing schedules differ slightly but follow a similar pattern. Methotrexate dosing may be adjusted based on tolerance, and all participants undergo standardized imaging and blood tests before treatment begins. During the study, participants have visits at 4, 8 (methotrexate group only), 12 weeks, and a final visit at 6 months. Assessments include safety blood work, side effect questionnaires, heart scans using FDG-PET and myocardial perfusion imaging, ECG, echocardiograms, biomarker blood tests, quality of life questionnaires, and optional bone density and cardiac MRI scans. Researchers monitor treatment compliance, medication side effects, heart function, and overall health. After 6 months, further care is managed by the treating physician. The main outcome measured is heart perfusion on PET scans at 6 months.
CONDITIONS
Brief Title
Cardiac Sarcoidosis Randomized Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with cardiac sarcoidosis showing one or more of advanced conduction system disease, significant sinus node dysfunction, ventricular arrhythmia, left ventricular dysfunction (LVEF < 50%), or right ventricular dysfunction (RVEF < 40%)
- No other explanation for these clinical features
- Nuclear imaging (FDG-PET with myocardial perfusion) within six months showing active cardiac sarcoidosis
- Positive biopsy for sarcoidosis (heart or other tissue) or CT chest showing features consistent with pulmonary sarcoidosis or lymphadenopathy
You will not qualify if you...
- Current or recent (within two months) non-topical treatment for sarcoidosis
- Oral or IV treatment for sarcoidosis lasting more than 5 days currently
- Currently taking Methotrexate or Prednisone for other health conditions
- Allergy or intolerance to Methotrexate or Prednisone
- Does not meet all inclusion criteria
- Unable or unwilling to give informed consent
- Participating in another randomized clinical trial
- Contraindication to PET imaging or severe claustrophobia
- Pregnancy or breastfeeding
- Women of childbearing age refusing medically acceptable contraception during the study
- Investigator believes participation is not in the patient's best interest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - 6 months
Participants receive randomized treatment with either low dose prednisone or a combination of methotrexate with prednisone and folic acid for cardiac sarcoidosis.
Visits at 4 weeks, 8 weeks (methotrexate arm only), 12 weeks, and 6 months
Trial Site Locations
Total: 30 locations
1
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06520
Actively Recruiting
2
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
3
University of Michigan-Michigan Medicine Cardiovascular Center
Ann Arbor, Michigan, United States, 48109-5853
Actively Recruiting
4
University of Minnesota
Minneota, Minnesota, United States, 55455
Not Yet Recruiting
5
Montefiore Medical Center
New York, New York, United States, 10467
Actively Recruiting
6
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
7
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
8
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
9
Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0053
Actively Recruiting
10
Libin Cardiovascular Institute of Alberta
Calgary, Alberta, Canada, T2N 2T9
Actively Recruiting
11
St. Paul's Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
12
Eastern Health Health Sciences Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Actively Recruiting
13
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Actively Recruiting
14
St. Joseph's Healthcare Centre
Hamilton, Ontario, Canada, L8N 4A6
Actively Recruiting
15
London Health Sciences Centre
London, Ontario, Canada, N6A 4A5
Actively Recruiting
16
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
17
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
18
CIUSSS-Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Actively Recruiting
19
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
Québec, Quebec, Canada, G1V 4G5
Actively Recruiting
20
CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
21
Hokkaido University
Sapporo, Kita 8, Nishi 5, Kita-Ku, Japan, 060-0808
Actively Recruiting
22
Chiba University
Chiba, Japan
Actively Recruiting
23
University of Fukui
Fukui, Japan
Not Yet Recruiting
24
St. Marrianna University
Kawasaki, Japan
Not Yet Recruiting
25
Nagoya City University
Nagoya, Japan
Actively Recruiting
26
National Cerebral and Cardiovascular Center (NCVC)
Osaka, Japan
Actively Recruiting
27
Sapporo Medical University
Sapporo, Japan
Actively Recruiting
28
Nippon Medical School
Tokyo, Japan
Actively Recruiting
29
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Not Yet Recruiting
30
Imperial College Healthcare Trust-NHS-Hammersmith Hospital
London, United Kingdom, W12 0HS
Not Yet Recruiting
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Research Team
D
David H Birnie, MD
J
Janine Ryan, BAH, CCRP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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