Status:
RECRUITING
Cardiovascular Genistein Therapy for Heart Failure Inflammation
Lead Sponsor:
University Medical Centre Ljubljana
Collaborating Sponsors:
Greenstone Biosciences
Conditions:
Heart Failure
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
PHASE2
Brief Summary
This Phase 1b/2a open-label study is designed to assess the safety and efficacy of genistein in patients with heart failure (HF). The investigation will focus on its impact on inflammatory and cardiom...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06501768
Start Date
July 1 2024
End Date
September 1 2026
Last Update
July 15 2024
Active Locations (1)
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1
UMC Ljubljana
Ljubljana, Slovenia, 1000