Author + information
- James L. Januzzia,b,
- Javed Butlera,b,
- G. Michael Felkera,b,
- Emmanuel Fombua,b,
- Alan Maisela,b,
- Kevin McCaguea,b,
- Ileana Pinaa,b,
- Margaret Prescotta,b,
- Jerome Riebmana,b and
- Scott Solomona,b
Background: Therapy with sacubitril/valsartan improves outcome in those with heart failure with reduced ejection fraction (HFrEF). Questions remain regarding effect of sacubitril/valsartan on left ventricular (LV) remodeling as well as its effects on circulating biomarkers (including B-type natriuretic peptide [BNP] and amino-terminal pro-BNP [NT-proBNP]) and patient-reported outcomes.
Methods: Approximately 830 patients starting sacubitril/valsartan per standard of care will be enrolled prior to initiation and titration (Figure). Key inclusion criteria include LVEF≤40%, class II-IV symptoms and stable loop diuretic dose. Key exclusion criteria include recent HF hospitalization or prior angioedema. Participants will undergo serial echocardiograms. Blood and urine will be collected for biomarker measurement. At each visit the Kansas City Cardiomyopathy Questionnaire (KCCQ)-23 and clinical outcomes (HF hospitalization, death, worsening HF) will be assessed. The primary endpoint will be degree of LV remodeling at one year relative to change in NT-proBNP. Other endpoints will correlate change in NT-proBNP with KCCQ-23 or clinical outcomes. Effect of initiation/titration of sacubitril/valsartan on a broad range of biomarkers (including comparison of several BNP methods) will be examined.
Conclusions: PROVE-HF is a 52 week evaluation of the effect of sacubitril/valsartan therapy on LV remodeling, biomarkers, patient-reported outcomes, and clinical events in HFrEF (NCT02887183).
Poster Hall, Hall C
Friday, March 17, 2017, 10:00 a.m.-10:45 a.m.
Session Title: Heart Failure and Cardiomyopathies: Is Heart Failure With a Normal EF for Real?
Abstract Category: 14. Heart Failure and Cardiomyopathies: Therapy
Presentation Number: 1121-253
- 2017 American College of Cardiology Foundation