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Circulating NEP and NEP Inhibition Study in Heart Failure With Preserved Ejection Fraction — CNEPi  

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:
A Proof of Concept Study to Determine the Efficacy of Entresto™ in HFpEF Based on Circulating Neprilysin Levels: The Circulating NEP and NEP Inhibition (CNEPi) Study

Clinical Trial Summary

To determine biomarker responses to Entresto™in patients with Heart Failure with preserved Ejection Fraction (HFpEF) and who have high or low serum neprilysin (NEP) levels.

Clinical Trial Description

This is a proof of concept single arm study in which 40 subjects with HFpEF will be assigned to Entresto™ 49/51 mg (sacubitril/valsartan) twice-daily for a total duration of up to 5 weeks of treatment. Blood will be drawn prior to and at completion of treatment. The primary endpoint measured is change in biomarkers with Entresto™ administration that reflect NEP activity and myocardial stress (NT pro-ANP, -BNP, -CNP) and drug action (cGMP). This endpoint has been well validated as a measure of Entresto™ drug response. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03506412
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase Phase 4
Start date June 25, 2018
Completion date March 23, 2021
View Details
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