Melissa A Daubert1, Kirkwood Adams2, Eric Yow3, Huiman X Barnhart4, Pamela S Douglas4, Susan Rimmer3, Casey Norris3, Lawton Cooper5, Eric Leifer5, Patrice Desvigne-Nickens5, Kevin Anstrom4, Mona Fiuzat6, Justin Ezekowitz7, Daniel B Mark4, Christopher M O'Connor8, James Januzzi9, G Michael Felker4. 1. Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina. Electronic address: melissa.daubert@duke.edu. 2. University of North Carolina, Chapel Hill, North Carolina. 3. Duke Clinical Research Institute, Durham, North Carolina. 4. Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina. 5. National Heart, Lung, and Blood Institute, Bethesda, Maryland. 6. Duke University Medical Center, Durham, North Carolina. 7. University of Alberta, Edmonton, Alberta, Canada. 8. Duke University Medical Center, Durham, North Carolina; Inova Heart and Vascular Institute, Falls Church, Virginia. 9. Massachusetts General Hospital, Boston, Massachusetts.
Abstract
OBJECTIVES: This study aims to assess the association between biomarker-guided therapy and left ventricular (LV) remodeling. BACKGROUND: In patients with heart failure with reduced ejection fraction (HFrEF), it is unclear if lowering natriuretic peptides reflects structural and functional changes in the heart. This study aims to assess the association between biomarker-guided therapy and left ventricular (LV) remodeling. METHODS: The GUIDE-IT (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) Echo Substudy was a multicenter study that randomized 268 patients with HFrEF (EF ≤40%) to either pro-B-type natriuretic peptide (NT-proBNP)-guided treatment or usual care. Echocardiograms were performed at baseline and 12 months in 124 patients. Remodeling indices and clinical outcomes were compared between treatment arms and by achievement of the NT-proBNP goal of <1,000 pg/ml at 12 months. RESULTS: At 12 months, the changes in EF and LV volumes were similar between the biomarker-guided and usual care arms with no difference in clinical outcomes; however, lowering NT-proBNP to <1,000 pg/ml, regardless of treatment strategy, was associated with a significantly greater increase in EF compared with those not reaching goal (9.9 ± 8.8% vs. 2.9 ± 7.9%; p < 0.001) and lower LV volumes. The extent of reverse remodeling correlated with the change in NT-proBNP: a decrease of 1,000 pg/ml was associated with an increase in EF of 6.7% and a reduction in systolic and diastolic volumes of 17.3 ml/m2 and 15.7 ml/m2, respectively. Adverse events were significantly lower among patients achieving the NT-proBNP goal (p < 0.001). CONCLUSIONS: Among patients with HFrEF, lowering NT-proBNP to <1,000 pg/ml by 12 months was associated with significant reverse remodeling and improved outcomes. A greater reduction in NT-proBNP was associated with more extensive reverse remodeling. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment [GUIDE-IT]; NCT01685840).
RCT Entities:
OBJECTIVES: This study aims to assess the association between biomarker-guided therapy and left ventricular (LV) remodeling. BACKGROUND: In patients with heart failure with reduced ejection fraction (HFrEF), it is unclear if lowering natriuretic peptides reflects structural and functional changes in the heart. This study aims to assess the association between biomarker-guided therapy and left ventricular (LV) remodeling. METHODS: The GUIDE-IT (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) Echo Substudy was a multicenter study that randomized 268 patients with HFrEF (EF ≤40%) to either pro-B-type natriuretic peptide (NT-proBNP)-guided treatment or usual care. Echocardiograms were performed at baseline and 12 months in 124 patients. Remodeling indices and clinical outcomes were compared between treatment arms and by achievement of the NT-proBNP goal of <1,000 pg/ml at 12 months. RESULTS: At 12 months, the changes in EF and LV volumes were similar between the biomarker-guided and usual care arms with no difference in clinical outcomes; however, lowering NT-proBNP to <1,000 pg/ml, regardless of treatment strategy, was associated with a significantly greater increase in EF compared with those not reaching goal (9.9 ± 8.8% vs. 2.9 ± 7.9%; p < 0.001) and lower LV volumes. The extent of reverse remodeling correlated with the change in NT-proBNP: a decrease of 1,000 pg/ml was associated with an increase in EF of 6.7% and a reduction in systolic and diastolic volumes of 17.3 ml/m2 and 15.7 ml/m2, respectively. Adverse events were significantly lower among patients achieving the NT-proBNP goal (p < 0.001). CONCLUSIONS: Among patients with HFrEF, lowering NT-proBNP to <1,000 pg/ml by 12 months was associated with significant reverse remodeling and improved outcomes. A greater reduction in NT-proBNP was associated with more extensive reverse remodeling. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment [GUIDE-IT]; NCT01685840).
Authors: James L Januzzi; Tariq Ahmad; Hillary Mulder; Adrian Coles; Kevin J Anstrom; Kirkwood F Adams; Justin A Ezekowitz; Mona Fiuzat; Nancy Houston-Miller; Daniel B Mark; Ileana L Piña; Gayle Passmore; David J Whellan; Lawton S Cooper; Eric S Leifer; Patrice Desvigne-Nickens; G Michael Felker; Christopher M O'Connor Journal: J Am Coll Cardiol Date: 2019-09-03 Impact factor: 24.094
Authors: Marat Fudim; Jacob P Kelly; Aaron D Jones; Omar F AbouEzzeddine; Andrew P Ambrosy; Stephen J Greene; Yogesh N V Reddy; Kevin J Anstrom; Brooke Alhanti; Gregory D Lewis; Adrian F Hernandez; G Michael Felker Journal: Am Heart J Date: 2019-11-16 Impact factor: 4.749