Amyloid Cardiomyopathy study: Genistein
Official title Genistein in trAnSthyretin recePtor Amyloid caRdiomyopathy
ClinicalTrials.gov ID: NCT06634108
What this study is testing
What is Genistein?
Genistein is an investigational plant-based supplement being studied to see if it helps people with amyloid cardiomyopathy. Genistein is designed to act as a phytoestrogen that may influence hormone-related pathways in the body.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if genistein is safe and if it can reduce inflammation and improve heart function and exercise ability in people with transthyretin amyloidosis.
- Who it's for
- It is looking for adults who have transthyretin amyloid cardiomyopathy.
- What's involved
- Participants will take oral genistein tablets at increasing doses for 12 weeks, then stop for 6 weeks. They will have blood tests, heart scans, and a 6‑minute walk test at several points during the study.
- Time commitment
- The total study lasts about 18 months, with visits for medication, blood draws, heart imaging, and exercise testing over the first 18 weeks and follow‑up visits afterward.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- Age: 40-80 years
- Heart failure with Reduced Ejection Fraction
- ischemic or nonischemic etiology
- LVEF \<40% by echocardiography, MUGA, or MRI
- ATTR cardiomyopathy
You likely can't join if
- Coronary intervention in the past 3 months
- Pregnancy
- Endometriosis
- Uterine fibroids
- including breast cancer
- predisposition to cancer such as abnormal mammogram
See the full eligibility 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 \ 125 pg/mL
- for participants \> 75 years old with NT-proBNP \> 450 pg/mL
- Coronary intervention in the past 3 months
- Pregnancy
- Endometriosis
- Uterine fibroids
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- London, Ontario, Canada
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at London, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.