臨床研究等提出・公開システム

Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial (CHASM CS- RCT)

Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial (CHASM CS- RCT)

Toshiyuki Nagai

Hokkaido University Graduate School of Medicine

Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido

nagai@med.hokudai.ac.jp

Atsushi Tada

Hokkaido University Hospital

Kita-14 Nishi-5, Kita-ku, Sapporo, Hokkaido

+81-11-716-1161

atsushi-tada.0409@med.hokudai.ac.jp

Recruiting

Nov. 05, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(1)Patients aged 18 years or older at the time of obtaining consent
(2)Patients with cardiac sarcoidosis (CS) who meet the following conditions(i) to (iii) and one or both of (iv) and (v)
(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) FDG-PET uptake suggestive of active CS within two months of enrollment (confirmed by PET core lab read)

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
(3)Patients who have given written consent from themselves or their guardians

1.Current or recent (within two months) non-topical treatment for sarcoidosis
2.Intolerance or contra-indication to Methotrexate or Prednisone
3.Pregnant women, lactating women, or patients who cannot consent to contraception during study participation
4.Patient is included in another randomized clinical trial
5.Patients for whom the investigator believes that the trial is not in the interest of the patient

Both

Cardiac Sarcoidosis

Subjects meeting the study inclusion/exclusion criteria will be randomized equally to receive either:

1. Prednisone 0.5 mg kg/day for 6-months (MAX dose 30 mg per day) or

2. Methotrexate 15-20 mg po, sc, or IM once a week for 6-months + Folic Acid 2 mg OD for 6 months + Prednisone 20 mg day for 1 month, then 10 mg OD for 1 month, then 5 mg OD for one month then STOP

Cardiac Sarcoidosis

Prednisone, Methotrexate

Summed perfusion rest score (SPRS) on FDG-PET scan [ Time Frame: 6 months ]

1. Mortality [ Time Frame: 6 months ]
2. Cardiovascular hospitalizations [ Time Frame: 6 months ]
3. Medication related adverse events [ Time Frame: 6 months ]
4. Modified Cleveland Clinic Glucocorticoid Toxicity Score [ Time Frame: 6 months ]
5. Glucocorticoid Toxicity Index [ Time Frame: 6 months ]
6. Patient reported symptoms related to medication [ Time Frame: 6 months ]
7. Medication compliance [ Time Frame: 6 months ]
8. Generic Quality of Life (SF 36) [ Time Frame: 6 months ]
Disease Specific Quality of Life (KSQ and SAT) [ Time Frame: 6 months ]
9. BMI [ Time Frame: 6 months ]
10. Blood pressure [ Time Frame: 6 months ]
11. HbA1C [ Time Frame: 6 months ]
12. T-score on bone density scan [ Time Frame: 6 months ]
13. FDG-PET and myocardial perfusion [ Time Frame: 6 month scan ]
14. Ventricular arrhythmia burden [ Time Frame: 6 months ]
15. Complete heart block [ Time Frame: 6 months ]
16. LVEF and RVEF assessed on echocardiogram [ Time Frame: 6 months ]
17. Highly sensitive Troponin I levels and BNP levels [ Time Frame: 6 months ]
18. CMR Endpoints [ Time Frame: 6 months ]

+81-11-706-7934

July. 06, 2021

No

Canada/ United States/United Kingdom