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An Exploratory Clinical Trial of Low-Frequency Therapy for Cardiac Sarcoidosis

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Cardiac sarcoidosis
Date of first enrollment	20/04/2026
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	A low-frequency stimulation device will be attached to the auricle, and stimulation will be administered once daily for 1 hour, using 1.5 mA, 25 Hz, and 250 us as the standard settings.

Outcome(s)

Primary Outcome

1. Number and duration of arrhythmic events per day, as assessed by Holter electrocardiography and pacemaker interrogation. 2. Echocardiographic parameters, including left ventricular ejection fraction. 3. Parameters assessed by 18F-FDG PET/CT, including FDG uptake. 4. Biomarkers. 5. Occurrence of death during low-frequency therapy. 6. Correlation between inflammation before and after low-frequency therapy and the expression of pathological factors.

Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Patients meeting all of the following criteria will be eligible for inclusion: 1. Individuals aged 18 years or older at the time informed consent is obtained. 2. Individuals diagnosed with cardiac sarcoidosis in accordance with the Japanese Circulation Society Guidelines for the Diagnosis and Treatment of Cardiac Sarcoidosis (2016 edition), including those with an implanted pacemaker or implantable cardioverter-defibrillator (ICD). 3. Individuals who, after receiving a full explanation regarding participation in this study, are able to actively comprehend the written informed consent document and from whom written informed consent has been obtained based on their own free will.
Exclude criteria	Patients meeting any of the following criteria will be excluded from the study: 1. Individuals with a history of progressive brain lesions. 2. Individuals receiving vagus nerve stimulation therapy. 3. Individuals with a history of severe cardiovascular disease. 4. Individuals with a history of hypersensitivity to glycerin. 5. Individuals who are pregnant or breastfeeding. 6. Individuals with skin hypersensitivity and a history of developing skin symptoms caused by metals or similar materials. 7. Individuals with difficulty taking food or medications orally. 8. Individuals with a history of dementia. 9. Individuals using a cardiac pacemaker or implantable cardioverter-defibrillator (ICD) that does not conform to ISO 14117. 10. Individuals otherwise deemed inappropriate for participation in the study by the Principal Investigator or a Sub-Investigator.