Actively Recruiting
Cardiac Sarcoidosis Randomized Trial
Led by Ottawa Heart Institute Research Corporation · Updated on 2026-05-05
194
Participants Needed
30
Research Sites
411 weeks
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
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).
CONDITIONS
Official Title
Cardiac Sarcoidosis Randomized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with cardiac sarcoidosis showing one or more of these: advanced heart block (Mobitz II or third degree), significant slow heart rate (<40 bpm awake), sustained or non-sustained ventricular arrhythmia, left ventricular ejection fraction below 50%, or right ventricular ejection fraction below 40%
- No other explanation for these heart symptoms
- FDG-PET nuclear imaging within 6 months showing active cardiac sarcoidosis
- Positive biopsy for sarcoidosis (either heart or other tissue) and/or CT chest showing signs of pulmonary sarcoidosis or lymph node enlargement in chest area
You will not qualify if you...
- Current or recent (within 2 months) non-topical treatment for sarcoidosis
- Current oral or intravenous treatment for sarcoidosis lasting more than 5 days
- Currently taking methotrexate or prednisone for another condition
- Intolerance or contraindication to methotrexate or prednisone
- Does not meet all inclusion criteria
- Unable or unwilling to provide informed consent
- Enrolled in another randomized clinical trial
- Contraindication to PET imaging or severe claustrophobia
- Pregnant or breastfeeding
- Women of childbearing age who refuse effective contraception during the study
- Investigator believes participation is not in patient's best interest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
D
David H Birnie, MD
CONTACT
J
Janine Ryan, BAH, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here