Investigating genistein for treating amyloid cardiomyopathy

Cardiovascular Genistein Therapy for Heart Failure Inflammation

This study is testing if genistein can safely help people with amyloid cardiomyopathy improve their heart health and exercise ability.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (other)
• Locations: 1 site (London, Ontario)
• Trial ID: NCT06634108 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-80 with heart failure and reduced ejection fraction due to amyloidosis.

Not a fit: Patients with recent coronary interventions, certain cancers, or those on specific diets or supplements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option for patients suffering from amyloid cardiomyopathy.

How similar studies have performed: Other studies have shown promise in targeting inflammatory pathways in heart failure, suggesting potential for success with this approach.

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

Where this trial is running

London, Ontario

• 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

Conditions: Amyloid Cardiomyopathy