NCT06634108RecruitingPhase 1/2
Genistein in trAnSthyretin recePtor Amyloid caRdiomyopathy
Cardiovascular Genistein Therapy for Heart Failure Inflammation
Source: ClinicalTrials.gov · Last updated 15 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. Blood samples will be collected at baseline, following each dose of genistein, and after a six-week placebo washout period. These samples will undergo extensive analyses, including profiling for inflammatory cytokines and novel molecular markers, and routine tests like CBC, Chem 7, LFT, HbA1c, NT-proBNP, CRP, troponin T, and serum TTR. RNA-seq analyses on peripheral blood mononuclear cells (PBMCs) and isolation of plasma exosomes for inflammatory biomarkers are also part of the protocol. Following ESC/AHA guidelines, echocardiography will assess cardiac structure and function, focusing on the left and right ventricles and valvular function. Additionally, exercise capacity will be evaluated through a standardized 6-minute walk test, and NT-proBNP levels will be measured as a cardiac stress biomarker. The trial will include an 18-week follow-up period post-enrolment, with the primary endpoint being the change in inflammatory markers from baseline to three months. Secondary endpoints are cardiac function and exercise capacity changes over the same timeframe. This study aims to provide significant insights into genistein's therapeutic potential for TTR Amyloidosis and its broader implications in managing heart failure. Following ethical committee approval and written informed consent, the Investigators aim is to enroll 40 participants. This is an open-label study. Each patient will receive genistein by mouth: 250 mg twice a day for 4 weeks (500 mg total/day), 500 mg twice a day for 4 weeks (1000 mg total/day), and 750 mg twice a day (1500 mg total/day) for an additional 4 weeks. This will be followed by a 6-week washout period to conclude the study. An 18-month study is anticipated based on the average enrollment rates. Results from this study are expected to offer critical insights for future larger studies.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 29 May 2024
- Start date
- 27 Sept 2024
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Diseases
- Heart failure
- NCT number
- NCT06634108
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 20
- From 27 Sept 2024 to the primary completion date, 1 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- hormone replacement therapy (HRT)
Other illness
- Cancer:
- including breast cancer
- predisposition to cancer such as abnormal mammogram
- family history
- BRCA1 or BRCA2 positive
- Patients on a vegan diet
- Uncontrolled diabetes (HgbA1c \>10%)
- Any patients who had been hospitalized in the past 3 months for reasons other than heart failure
- 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
Lab values
- Liver dysfunction:
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3X ULN
- total bilirubin greater than 1.5 times ULN
- Renal dysfunction (eGFR less than 25 mL/min/1.73 m2)
- Cytopenia:
- leukocytopenia
- hemoglobin \< 9 mg/dl
- platelets \<100x103/mm3
Other
- Coronary intervention in the past 3 months
- Pregnancy
- Endometriosis
- Uterine fibroids
- 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
- thyroid supplement
- Coagulopathies
- NYHA Functional Class I or Functional Class IV symptoms.
Who the study is looking for
- 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
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Regional Health Science Centre Coordinator of this site? Confirm its status | London | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.