MYSTICS-RCT

JRCT ID: jRCTs051230077

Registered date:25/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cardiac sarcoidosis
• Date of first enrollment: 25/07/2023
• Target sample size: 120
• Study type: Interventional
• Intervention(s): We will randomly assign cardiac sarcoidosis patients diagnosed with steroid-resistant or relapsed cardiac sarcoidosis to a group receiving a combination of prednisolone and methotrexate, and a group receiving an increased dose of prednisolone, and compare the improvement of cardiac sarcoidosis activity after 24 weeks using rest myocardial blood flow SPECT.

Outcome(s)

• Primary Outcome: Worsening in the myocardial damage findings of cardiac sarcoidosis on rest myocardial blood flow SPECT (resting perfusion defect score [SPRS]) at 24 weeks after intervention (core lab analysis).

Secondary Outcome

The incidence of composite endpoint (cardiovascular death or fatal arrhythmia or hospitalization for heart failure)
The incidence of cardiovascular death
The incidence of all-cause mortality
The incidence of all-cause hospitalization
The incidence of hospitalization for heart failure
The incidence of sustained ventricular tachycardia/ventricular fibrillation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

Patients meeting all 5 criteria below:

Patients who are 18 years of age or older but younger than 90 years of age at the time of obtaining consent.
Patients who meet the diagnostic criteria for cardiac sarcoidosis in the Japanese guideline.
Patients who have received treatment with adrenal cortical steroids for more than 24 weeks for cardiac sarcoidosis or have been treated in the past.
Patients who have demonstrated accumulation indicating activity on F18-fluorodeoxyglucose-positron emission tomography (FDG-PET) or gallium scintigraphy within 2 months prior to obtaining consent for this trial.
Patients who have provided written consent either by themselves or by a legal representative.

Exclude criteria

Patients who meet any of the following criteria are excluded from participation in this study:

Patients who are intolerant or contraindicated to methotrexate or prednisolone.
Patients who are receiving medication with methotrexate or other immunosuppressants.
Patients with poorly controlled diabetes (HbA1c >= 9.0%).
Pregnant, lactating, or women who are unable to consent to contraception during the trial.
Men who are unable to consent to contraception during the trial.
Patients undergoing maintenance hemodialysis.
Patients who have already participated in other clinical trials or plan to participate during the study period.
Patients deemed inappropriate for participation in this trial by the study principal investigator or co-investigator for other reasons.

Related Information

• Primary Sponsor: Izumi Chisato