🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Genistein in trAnSthyretin recePtor Amyloid caRdiomyopathy

RecruitingPhase 1, Phase 2Ages 40 Years - 80 YearsAllLondon Health Sciences Centre Research Institute …
NCT06634108 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

This Phase 1b/2a study aims to investigate the safety and efficacy of genistein in patients with Transthyretin (TTR) Amyloidosis. The focus is on its impact on inflammatory and cardiometabolic biomarkers, along with the effects on cardiac function and exercise capacity. Blood samples will be collected at baseline, following each dose of genistein, and after a six-week placebo washout period. These samples will undergo extensive analyses, including profiling for inflammatory cytokines and novel molecular markers, and routine tests like CBC, Chem 7, LFT, HbA1c, NT-proBNP, CRP, troponin T, and serum TTR. RNA-seq analyses on peripheral blood mononuclear cells (PBMCs) and isolation of plasma exosomes for inflammatory biomarkers are also part of the protocol. Following ESC/AHA guidelines, echocardiography will assess cardiac structure and function, focusing on the left and right ventricles a

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
Inclusion Criteria: * Age: 40-80 years * Heart failure with Reduced Ejection Fraction * ischemic or nonischemic etiology * LVEF \<40% by echocardiography, MUGA, or MRI * ATTR cardiomyopathy * any LVEF by echocardiography, MUGA, or MRI * Stable optimally tolerated dosages of HF therapies for 3 months with no change in medical management regimen for at least 1 month * NT-proBNP * for participants \< 75 years old with NT-proBNP \> 125 pg/mL * for participants \> 75 years old with NT-proBNP \> 450 pg/mL Exclusion Criteria: * Coronary intervention in the past 3 months * Pregnancy * Endometriosis * Uterine fibroids * Cancer: * including breast cancer * predisposition to cancer such as abnormal mammogram * family history * BRCA1 or BRCA2 positive * Patients on a vegan diet * Patients taking supplements such as isoflavonoid, genistein, or resveratrol * Ethanol abuse * Men: \>4 drinks on any day or more than 14 drinks per week * Women: \>3 drinks on any day or more than 7 drinks per week * Liver dysfunction: * aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3X ULN * total bilirubin greater than 1.5 times ULN * hormone replacement therapy (HRT) * thyroid supplement * Renal dysfunction (eGFR less than 25 mL/min/1.73 m2) * Uncontrolled diabetes (HgbA1c \>10%) * Coagulopathies * Cytopenia: * leukocytopenia * hemoglobin \< 9 mg/dl * platelets \<100x103/mm3 * Any patients who had been hospitalized in the past 3 months for reasons other than heart failure * NYHA Functional Class I or Functional Class IV symptoms. * Acute bacterial or viral infectious disease, or acute exacerbation of a chronic infectious disease * allergy to genistein or inulin * allergy to perflutren dye used in contrast echocardiography
💊

What it tests

  • Genistein
📍

Where

1 site
London Regional Health Science Centre
London, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy