Ignite Creation Date:
2024-07-17 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501768
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-01
Brief Title:
Cardiovascular Genistein Therapy for Heart Failure Inflammation
Sponsor:
University Medical Centre Ljubljana
Organization:
University Medical Centre Ljubljana
Study Overview
Official Title:
A Pilot Clinical Trial of Cardiovascular Genistein Therapy for Heart Failure Inflammation
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARDIOGEN
Brief Summary:
This Phase 1b2a 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 cardiometabolic biomarkers as well as its effects on cardiac function and exercise capacity
Blood samples will be collected at baseline following each administration of genistein and after a six-week placebo washout period These samples will be subjected to comprehensive analyses to evaluate inflammatory cytokines and novel molecular markers Routine tests including Complete Blood Count CBC Basic Metabolic Panel Chem 7 Liver Function Tests LFT Hemoglobin A1c HbA1c N-terminal pro b-type natriuretic peptide NT-proBNP C-Reactive Protein CRP and troponin T will be performed Advanced assessments will include RNA sequencing RNA-seq on peripheral blood mononuclear cells PBMCs and the isolation of plasma exosomes to identify inflammatory biomarkers In addition a subset of the blood samples will be used to generate induced pluripotent stem cells iPSCs to further explore the treatments impact on heart failure-related inflammatory markers
Echocardiography in accordance with the European Society of Cardiology ESC and the American Heart Association AHA guidelines will be utilized to evaluate cardiac structure and function with a specific focus on the left and right ventricular functions and valvular integrity Exercise capacity will be gauged through a standardized six-minute walk test Levels of NT-proBNP will be measured as an indicator of cardiac stress and function
Participants will be followed up for 18 weeks post-enrolment with the primary endpoint being the change in inflammatory markers from baseline to the three-month mark Secondary endpoints will include changes in cardiac function and exercise capacity over the same period The trial aims to enrol 40 participants following ethical committee approval and the acquisition of written informed consent Each patient will receive genistein at a dosing regimen starting with 250 mg twice daily BID for 4 weeks escalating to 500 mg BID for the subsequent 4 weeks and 750 mg BID for another 4 weeks culminating in a 6-week follow-up period
The insights garnered from this study are expected to be pivotal in guiding future larger-scale studies and to elucidate the therapeutic potential of genistein in the management of heart failure
Blood samples will be collected at baseline following each administration of genistein and after a six-week placebo washout period These samples will be subjected to comprehensive analyses to evaluate inflammatory cytokines and novel molecular markers Routine tests including Complete Blood Count CBC Basic Metabolic Panel Chem 7 Liver Function Tests LFT Hemoglobin A1c HbA1c N-terminal pro b-type natriuretic peptide NT-proBNP C-Reactive Protein CRP and troponin T will be performed Advanced assessments will include RNA sequencing RNA-seq on peripheral blood mononuclear cells PBMCs and the isolation of plasma exosomes to identify inflammatory biomarkers In addition a subset of the blood samples will be used to generate induced pluripotent stem cells iPSCs to further explore the treatments impact on heart failure-related inflammatory markers
Echocardiography in accordance with the European Society of Cardiology ESC and the American Heart Association AHA guidelines will be utilized to evaluate cardiac structure and function with a specific focus on the left and right ventricular functions and valvular integrity Exercise capacity will be gauged through a standardized six-minute walk test Levels of NT-proBNP will be measured as an indicator of cardiac stress and function
Participants will be followed up for 18 weeks post-enrolment with the primary endpoint being the change in inflammatory markers from baseline to the three-month mark Secondary endpoints will include changes in cardiac function and exercise capacity over the same period The trial aims to enrol 40 participants following ethical committee approval and the acquisition of written informed consent Each patient will receive genistein at a dosing regimen starting with 250 mg twice daily BID for 4 weeks escalating to 500 mg BID for the subsequent 4 weeks and 750 mg BID for another 4 weeks culminating in a 6-week follow-up period
The insights garnered from this study are expected to be pivotal in guiding future larger-scale studies and to elucidate the therapeutic potential of genistein in the management of heart failure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None