Circulating NEP and NEP Inhibition Study in Heart Failure With Preserved Ejection Fraction (CNEPi)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03506412|
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : January 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure With Preserved Ejection Fraction||Drug: Entresto™ 49Mg-51 mg tablet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Entresto™ will be administered to subjects with high and low circulating neprilysin (NEP) levels.|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 25, 2018|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
HFpEF patients will be given Entresto™
Drug: Entresto™ 49Mg-51 mg tablet
Entresto™ 49Mg-51 mg will be given twice daily orally for 5 weeks
- Change From Baseline of Biomarkers Based on NEP Levels with Entresto™ Administration [ Time Frame: 5 weeks ]The effect of administering Entresto™ to subjects with "high" or "low" NEP levels will be studied. Favorable response to Entresto™ therapy in these subjects will be assessed by evaluating a change in biomarkers that reflect NEP activity. Entresto™ is FDA approved for use in HFrEF and will be administered as recommended in the drug labeling information as an off label use in HFpEF as 49/51 mg twice-daily.
- Change From Baseline in NT-proANP, NT-proBNP and NT-proCNP [ Time Frame: 5 weeks ]Evaluation of NT-proANP, NT-proBNP and NT-proCNP was performed by laboratory testing.
- Change From Baseline in Plasma Cyclic Guanine Monophosphate (cGMP) [ Time Frame: 5 weeks ]Evaluation of cGMP was performed by laboratory testing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506412
|Contact: Nancy G Acker, BSN||(507) email@example.com|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Naveen L Pereira, MD||Mayo Clinic|