Genistein treatment for heart failure inflammation
A Pilot Clinical Trial of Cardiovascular Genistein Therapy for Heart Failure Inflammation
This study is testing whether genistein can help reduce inflammation and improve heart function and exercise ability in people with heart failure.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT06501768 on ClinicalTrials.gov |
What this trial studies
This Phase 1b/2a open-label study evaluates the safety and efficacy of genistein in patients with heart failure. The study focuses on its effects on inflammatory and cardiometabolic biomarkers, cardiac function, and exercise capacity. Blood samples will be collected at various stages to analyze inflammatory cytokines and other molecular markers, alongside routine tests. Advanced assessments will include RNA sequencing and the isolation of plasma exosomes to identify inflammatory biomarkers.
Who should consider this trial
Good fit: Ideal candidates include individuals with heart failure of ischemic or nonischemic origin and an LVEF of less than 40%.
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 treatment could improve heart function and reduce inflammation in patients with heart failure.
How similar studies have performed: While the approach is innovative, similar studies have shown promise in targeting inflammation in heart failure, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presence of heart failure of ischemic or nonischemic etiology with LVEF \<40%. * ATTR cardiomyopathy with any LVEF. * Stable optimally tolerated dosages of HF therapies for 3 months with no change in medical management regimen for at least 1 month. * NT-proBNP \>350 pg/mL. Exclusion Criteria: * Coronary intervention in the past 3 months. * Pregnancy * Cancer * Patients on a vegan diet * Patients taking supplements such as isoflavonoid or resveratrol. * Ethanol abuse (men: \>4 drinks on any day or more than 14 drinks by week; women: \>3 drinks on any day or more than 7 drinks per week) * Liver dysfunction (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3X ULN or total bilirubin greater than 1.5 times ULN) * Renal dysfunction (eGFR less than 25 mL/min/1.73 m2) * Uncontrolled diabetes (HgbA1c \>10%) * Coagulopathies * Cytopenia (leukocytopenia or hemoglobin \< 9 mg/dl or 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 * Known hypersensitivity to soy.
Where this trial is running
Ljubljana
- UMC Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Bojan Vrtovec, MD, PhD
- Email: bojan.vrtovec@kclj.si
- Phone: +3861 522 1157
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.