Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536309
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Neprilysin Inhibition to Reduce Myocardial Fibrosis in Heart Failure With Preserved Ejection Fraction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neprilysin Inhibition to Reduce Myocardial Fibrosis in Heart Failure With Preserved Ejection Fraction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cardiac magnetic resonance imaging MRI measures of myocardial interstitial fibrosis MIF are elevated in heart failure with preserved ejection fraction HFpEF patients and associated with poor prognosis Extracellular volume ECV is the most reproducible and best validated cardiac MRI measure of MIF Sacubitrilvalsartan reduces histological MIF in mice and levels of some extracellular matrix regulatory proteins in humans with HFpEF However the effect of sacubitrilvalsartan on robust measures of MIF in humans is unknown Demonstrating reductions in ECV with sacubitrilvalsartan would clarify the mechanism of this approved medication Given the borderline reduction in heart failure hospitalizations with sacubitrilvalsartan and the heterogeneity of HFpEF pathophysiology this result would suggest that neprilysin inhibition may particularly benefit HFpEF patients with greater MIF The investigators propose a proof-of-concept clinical trial to evaluate the effect of neprilysin inhibition sacubitrilvalsartan vs valsartan alone on cardiac MRI measures of fibrosis principally ECV and circulating protein levels
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None