Cardiac Sarcoidosis multi-center randomized controlled trial (CHASM CS- RCT)

Area of Science:

• Cardiology
• Immunology
• Clinical Trials

Background:

• Cardiac sarcoidosis affects approximately 5% of sarcoidosis patients, with treatment based on limited evidence.
• Current standard treatment with prednisone has significant adverse effects.
• There is a need for randomized controlled trials to establish optimal treatment strategies.

Purpose of the Study:

• To evaluate the efficacy and quality of life outcomes of a low-dose prednisone/methotrexate combination versus standard-dose prednisone in active cardiac sarcoidosis.
• To test the hypothesis that the combination therapy is non-inferior in efficacy and superior in quality of life.

Main Methods:

• A multicenter randomized controlled trial (CHASM CS-RCT) involving patients with active cardiac sarcoidosis.
• Patients were randomized 1:1 to receive either standard prednisone or a tapering prednisone dose combined with methotrexate.
• The primary endpoint was the summed perfusion rest score on 6-month PET scans, measuring myocardial fibrosis.

Main Results:

• The study is designed to establish non-inferiority of the combination therapy compared to standard prednisone.
• The combination therapy is hypothesized to lead to a significantly better quality of life due to reduced side effects.
• This trial sets the stage for a multi-center, multinational cardiac sarcoidosis clinical trials network.

Conclusions:

• This is the first clinical trial for cardiac sarcoidosis, aiming to provide high-quality data for treatment decisions.
• Proving non-inferiority of the alternative regimen would support its favorable comparison to standard steroids.
• The trial will facilitate a collaborative network for future research in cardiac sarcoidosis.