Investigating genistein for treating amyloid cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1b/2a study evaluates the safety and efficacy of genistein in patients with Transthyretin (TTR) Amyloidosis. The study focuses on its effects on inflammatory and cardiometabolic biomarkers, cardiac function, and exercise capacity. Blood samples will be collected for extensive analyses, including profiling inflammatory cytokines and routine tests, while echocardiography will assess cardiac structure and function. Participants will also undergo a standardized exercise capacity evaluation.

Why it matters

Who can join: the full rules

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

Where it's running

• London Regional Health Science Centre
  London, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Mark JK Chandy, MD PhD — Lawson
• Study coordinator: Mark JK Chandy, MD PhD
• Email: mark.chandy@lhsc.on.ca
• Phone: 5196612111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Acoramidis for ATTR-CM: Cardiac Imaging Study

  This study tests whether acoramidis can improve heart structure and function in people with transthyretin amyloid cardiomyopathy.

  Recruiting Phase 4 Eidos Therapeutics, a BridgeBio company · St Louis, Missouri · NCT07695701

• Hungarian National Systemic Amyloidosis Registry

  This registry collects medical data from adults with systemic amyloidosis across Hungary to help understand how the disease is diagnosed and treated in real-world practice.

  Recruiting at 12 sites Semmelweis University · Balatonfüred and 11 other locations · NCT07689331

• Cardiac MRI blood-flow imaging to distinguish types of hypertrophic cardiomyopathy

  We will try cardiac MRI perfusion imaging to see if blood-flow patterns can distinguish people with different forms of hypertrophic cardiomyopathy, including genetic carriers and related conditions like Fabry disease and cardiac amyloidosis.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna, BO · NCT07382128

• Enavogliflozin for Amyloid Cardiomyopathy

  This study tests whether Enavogliflozin helps people with amyloid cardiomyopathy and heart failure by comparing it to placebo in two treatment periods.

  Recruiting at 2 sites Phase 4 Seoul St. Mary's Hospital · Seoul and 1 other locations · NCT07240844

• Preventing transthyretin amyloidosis in young carriers of a genetic variant

  This study is testing if a medication called acoramidis can help prevent transthyretin amyloidosis in young adults who carry a specific genetic variant that puts them at risk for the disease.

  Recruiting at 104 sites Phase 3 Eidos Therapeutics, a BridgeBio company · La Jolla, California and 103 other locations · NCT06563895

• Personalized exercise program for patients with transthyretin cardiac amyloidosis

  This study is testing a personalized exercise program to see if it can help people with transthyretin cardiac amyloidosis feel stronger and improve their quality of life.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT05797857

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.