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Optimal Medical Therapy Estimated by FDG PET/CT in
Myocardial Sarcoidosis
(OMT-CS study)

Estimated by FDG PET/CT in Myocardial Sarcoidosis
(CS study)

62

The mean age of this study subjects was 62.8 years, 44 (74.6%) were female, the median BNP was 59.4 pg/mL, and the mean EF was 47.5%. Comorbidities included hypertension in 17 patients (28.8%), dyslipidemia in 12 patients (20.3%), diabetes in 7 patients (11.9%), post pacemaker implantation in 23 patients (39%), post ICD implantation in 9 patients (15.3%), and post CRT implantation in 11 patients (18.6%). As for sarcoidosis in other organs, pulmonary sarcoidosis was the most common type of sarcoidosis in 49 patients (83.1%), ocular sarcoidosis in 13 patients (22%), and patients with isolated cardiac sarcoidosis in 4 patients (6.8%).

Because cardiac sarcoidosis is a rare disease, we expected that patient enrollment would be hard, but the enrollment was much faster than expected, with more than 300 patients referred from over 30 affiliated hospitals. However, prednisolone had a strong effect on abnormal FDG accumulation, and fewer patients than expected were randomized as a treatment resistant group, so the study itself took more than 4 years. In the end, against a target of 70 patients, 59 patients with cardiac sarcoidosis were analyzed. Of the 59 patients, 1 died of heart failure, 1 died of aortic dissection, and 1 refused prednisone treatment within 6 months, and 56 underwent follow up FDG PET imaging. Of the 47 responders, 45 were classified as responders and 2 as poor responders after another 6 months of prednisone treatment. The estimated number of patients to be assigned was 20 in total (10/10), of the 11 poor responders, 5 were randomized to methotrexate and 6 to reprednisone.

During the clinical study period, there was one was died by heart failure, one by aortic dissection, one sudden death at home, 4 patients required hospitalization for heart failure, and one patient had ventricular tachycardia.

The primary endpoint was the improvement rate of TLG levels by 18FDG-PET/CT imaging in the steroid-treated and methotrexate-treated groups at 12 months (18 months) and for the secondary endpoint, the results of echocardiography and various biomarkers were examined, and there were no significant differences between the prednisone re-treatment group (n=6) and the MTX group (n=5). However, in the group of patients with abnormal FDG accumulation in the heart, treatment with prednisone for 6 months did not significantly change BNP or TnT levels, but did significantly reduce ACE levels (13.4, 9.9, P = 0.001) and sIL2R (529.8, 324.6, P < 0.001). Volume analysis of abnormal FDG accumulation by GI-PET showed a significant decrease in volume (50.5 (16.4-98.9) , 0.3 (0.0-2.9), P<0.001), SUVmax (6.9, 2.8, P<0.001), TLG (203.3 (66.3-372.4) , 1. TLG (203.3 (66.3-372.4) , 1.0 (0.0-9.2), P<0.001).

After 6 months of prednisone treatment for cardiac sarcoidosis, 80.4% of patients had a reduction in the extent of abnormal FDG accumulation, and when the poor-responder group was re-treated with methotrexate or re-prednisone, there was no significant difference in the treatment effect between two groups.

Mar. 31, 2023

No

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https://jrct.mhlw.go.jp/latest-detail/jRCTs041180111

Murohara Toyoaki

Department of Cardiology, Nagoya University Graduate School of Medicine

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan

murohara@med.nagoya-u.ac.jp

Morimoto Ryota

Department of Cardiology, Nagoya University Graduate School of Medicine

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan

+81-52-741-2111

ryota.m0726@med.nagoya-u.ac.jp

Complete

Oct. 08, 2016

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

Cardiac sarcoidosis

1, Bone marrow suppression
2, Chronic hepatic disease
3, Chronic kidney disease
4, Insulin using
5, Active infection
6, Unsuitable patient
7, Under 20 years of age

Both

Cardiac sarcoidosis

After using PSL for 6 months, patients were classified by decreasing rate of TLG. If TLG is decreasing over 70%, PSL was prescribed 5mg/day for more 6 months. If TLG is decreasing under 70%, arm A: PSL was prescribed 30mg/day and diminishing PSL 5mg per month for more 6 months arm B: MTX (6mg/week) and folic acid (5mg/week) was prescribed for more 6 months

Cardiac sarcoidosis

Decreasing rate of TLG

C14

Decreasing rate of TLG by PSL therapy for 12 (18) months

1, Systolic and/or diastolic function
2, Respiratory function
3, Exercise function
4, Prognosis

+81-52-744-2479

Feb. 28, 2019

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