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New treatment option for Amyloid Cardiomyopathy
Official title Genistein in trAnSthyretin recePtor Amyloid caRdiomyopathy
ClinicalTrials.gov ID: NCT06634108
What this study is testing
What is Genistein?
Genistein is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for amyloid cardiomyopathy.
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
- 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.
- 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
- Cancer:
- including breast cancer
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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 - 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 - 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?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.