Actively Recruiting
Cardiovascular Genistein Therapy for Heart Failure Inflammation
Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2025-06-15
20
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
L
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
G
Greenstone Biosciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating genistein, a soybean-derived compound, in patients with Transthyretin (TTR) Amyloidosis and heart failure. This Phase 1b/2a open-label study aims to investigate genistein's effects on inflammation, cardiac function, and exercise capacity, focusing on its impact on inflammatory and cardiometabolic biomarkers. The study addresses the role of inflammation in heart failure and explores genistein as a potential adjunct to existing treatments for amyloid cardiomyopathy. Participants will receive escalating oral doses of genistein: 250 mg twice daily for 4 weeks, then 500 mg twice daily for 4 weeks, and finally 750 mg twice daily for another 4 weeks. This is followed by a 6-week placebo washout period. Blood and stool samples will be collected at baseline, after each dosage period, and following washout. Echocardiography and a 6-minute walk test will be performed at baseline and 3 months to assess cardiac structure, function, and exercise capacity. Throughout the 18-week study, researchers will monitor inflammatory markers, cardiac biomarkers, and metabolic profiles at multiple timepoints. Cardiac assessments will include evaluations of ventricular function and valvular performance. Exercise capacity will be measured with the 6-minute walk test. The study also includes extensive blood analyses, RNA sequencing, and plasma exosome isolation to understand genistein's effects. Safety and efficacy outcomes aim to inform future larger trials for treating ATTR amyloid cardiomyopathy.
CONDITIONS
Brief Title
Genistein in trAnSthyretin recePtor Amyloid caRdiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 80 years
- Diagnosis of heart failure with reduced ejection fraction (LVEF <40%) due to ischemic or nonischemic causes
- Diagnosis of transthyretin amyloid cardiomyopathy with any LVEF
- Stable and optimal heart failure medication doses for at least 3 months with no changes in the last month
- NT-proBNP level above 125 pg/mL if under 75 years old, or above 450 pg/mL if 75 years or older
You will not qualify if you...
- Coronary intervention within the past 3 months
- Pregnancy
- Endometriosis
- Uterine fibroids
- Current or predisposition to cancer, including breast cancer and abnormal mammograms
- Family history of cancer or BRCA1/BRCA2 positive
- Vegan diet
- Taking supplements such as isoflavonoid, genistein, or resveratrol
- Excessive alcohol use (men: more than 4 drinks any day or 14 per week; women: more than 3 drinks any day or 7 per week)
- Liver dysfunction with elevated AST, ALT, or bilirubin levels
- Use of hormone replacement therapy or thyroid supplements
- Severe kidney disease (eGFR less than 25 mL/min/1.73 m2)
- Uncontrolled diabetes (HbA1c greater than 10%)
- Blood clotting disorders
- Low blood counts including leukocytopenia, hemoglobin below 9 mg/dl, or low platelets
- Hospitalization in the past 3 months for reasons other than heart failure
- NYHA Functional Class I or IV symptoms
- Acute infections or flare-ups of chronic infections
- Allergy to genistein, inulin, or perflutren dye used in echocardiography
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for initial telephone screening and informed consent
Duration - 12 weeks
Participants receive escalating doses of genistein over 12 weeks with blood and stool sample collections and assessments of inflammatory and cardiac markers.
Visits at baseline and at weeks 4, 8, and 12 for blood and stool sample collections and assessments
Duration - 6 weeks
Participants have a 6-week washout period after treatment with final fasting blood and stool sample collections and cardiac assessments.
1 visit at week 18 for fasting blood and stool sample collection and cardiac assessments
Trial Site Locations
Total: 1 location
1
London Regional Health Science Centre
London, Ontario, Canada, N6A 5A5
Actively Recruiting
Research Team
M
Mark JK Chandy, MD PhD
K
Kerry-Ann Nakrieko, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here