Genistein Treatment for Amyloid Cardiomyopathy and Heart Failure A Phase 1b2a Study Evaluating Safety, Inflammation, and Heart Function

What this Trial Is About

Researchers are evaluating genistein, a soybean-derived compound, in patients with Transthyretin TTR Amyloidosis and heart failure. This Phase 1b2a open-label study aims to investigate genisteins effects on inflammation, cardiac function, and exercise capacity, focusing on its impact on inflammatory and cardiometabolic biomarkers. The study addresses the role of inflammation in heart failure and explores genistein as a potential adjunct to existing treatments for amyloid cardiomyopathy. Participants will receive escalating oral doses of genistein 250 mg twice daily for 4 weeks, then 500 mg twice daily for 4 weeks, and finally 750 mg twice daily for another 4 weeks. This is followed by a 6-week placebo washout period. Blood and stool samples will be collected at baseline, after each dosage period, and following washout. Echocardiography and a 6-minute walk test will be performed at baseline and 3 months to assess cardiac structure, function, and exercise capacity. Throughout the 18-week study, researchers will monitor inflammatory markers, cardiac biomarkers, and metabolic profiles at multiple timepoints. Cardiac assessments will include evaluations of ventricular function and valvular performance. Exercise capacity will be measured with the 6-minute walk test. The study also includes extensive blood analyses, RNA sequencing, and plasma exosome isolation to understand genisteins effects. Safety and efficacy outcomes aim to inform future larger trials for treating ATTR amyloid cardiomyopathy.

Genistein in trAnSthyretin recePtor Amyloid caRdiomyopathy