NCT06634108 Genistein in trAnSthyretin recePtor Amyloid caRdiomyopathy
| NCT ID | NCT06634108 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Amyloid Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-09-27 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-09-27 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 and valvular function. Additionally, exercise capacity will be evaluated through a standardized 6-minute walk test, and NT-proBNP levels will be measured as a cardiac stress biomarker. The trial will include an 18-week follow-up period post-enrolment, with the primary endpoint being the change in inflammatory markers from baseline to three months. Secondary endpoints are cardiac function and exercise capacity changes over the same timeframe. This study aims to provide significant insights into genistein's therapeutic potential for TTR Amyloidosis and its broader implications in managing heart failure. Following ethical committee approval and written informed consent, the Investigators aim is to enroll 40 participants. This is an open-label study. Each patient will receive genistein by mouth: 250 mg twice a day for 4 weeks (500 mg total/day), 500 mg twice a day for 4 weeks (1000 mg total/day), and 750 mg twice a day (1500 mg total/day) for an additional 4 weeks. This will be followed by a 6-week washout period to conclude the study. An 18-month study is anticipated based on the average enrollment rates. Results from this study are expected to offer critical insights for future larger studies.
Eligibility Criteria
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
Contact & Investigator
Mark JK Chandy, MD PhD
PRINCIPAL INVESTIGATOR
Lawson
Frequently Asked Questions
Who can join the NCT06634108 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Amyloid Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06634108 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06634108 currently recruiting?
Yes, NCT06634108 is actively recruiting participants. Contact the research team at mark.chandy@lhsc.on.ca for enrollment information.
Where is the NCT06634108 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT06634108 clinical trial?
NCT06634108 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is Mark JK Chandy, MD PhD at Lawson. The trial plans to enroll 20 participants.