Genistein in trAnSthyretin recePtor Amyloid caRdiomyopathy

Q: Who can participate in NCT06634108?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT06634108?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

Cardiovascular Genistein Therapy for Heart Failure Inflammation

Genistein in trAnSthyretin recePtor Amyloid caRdiomyopathy (NCT06634108) is a Phase 1 / Phase 2 interventional studying Amyloid Cardiomyopathy, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Amyloid Cardiomyopathy, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Genistein

The genistein capsules are manufactured and obtained from MCS Formulas, and each capsule contains 250 mg genistein and 50 mg inulin. The genistein is certified to be 98% pure genistein by HPLC and is certified by Good Laboratory Practice (GLP). They will consume 250 mg of genistein BID (500 mg total) by mouth for the first 4 weeks before blood and stool samples are collected. Then, participants will take 500 mg of genistein BID (1000 mg total) for the next 4 weeks before collecting fasting blood and stool samples. Afterward, participants will take 750 mg of genistein BID (1500 mg total) for 4 weeks before collecting fasting blood and stool samples. Afterward, participants will have a washout for 6 weeks before returning for fasting blood and stool sample collection.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

London Regional Health Science Centre

London, Ontario, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06634108), the sponsor (London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06634108 clinical trial studying?

Who can participate in NCT06634108?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06634108?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06634108. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06634108. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.