NCT03506412

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
DRUG	Entresto™ 49Mg-51 mg tablet	Entresto™ 49Mg-51 mg will be given twice daily orally for 5 weeks

Timeline

• Start date: 2018-06-25
• Primary completion: 2021-03-23
• Completion: 2021-03-23
• First posted: 2018-04-24
• Last updated: 2022-02-04
• Results posted: 2022-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study