G Michael Felker1, Tariq Ahmad2, Kevin J Anstrom3, Kirkwood F Adams4, Lawton S Cooper5, Justin A Ezekowitz6, Mona Fiuzat2, Nancy Houston-Miller7, James L Januzzi8, Eric S Leifer5, Daniel B Mark2, Patrice Desvigne-Nickens5, Gayle Paynter3, Ileana L Piña9, David J Whellan10, Christopher M O'Connor2. 1. Division of Cardiology, Duke University Medical Center, Durham, North Carolina; Division of Cardiology, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. Electronic address: michael.felker@duke.edu. 2. Division of Cardiology, Duke University Medical Center, Durham, North Carolina; Division of Cardiology, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. 3. Division of Cardiology, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. 4. Division of Cardiology, University of North Carolina, Chapel Hill, North Carolina. 5. Office of Biostatistics Research, National Heart, Lung, and Blood Institute, Bethesda, Maryland. 6. Division of Cardiology, University of Alberta, Alberta, Canada. 7. Division of Cardiology, Stanford University, Palo Alto, California. 8. Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts. 9. Division of Cardiology, Montefiore-Einstein Medical Center, Bronx, New York. 10. Division of Cardiology, Thomas Jefferson University, Philadelphia, Pennsylvania.
Abstract
OBJECTIVES: The GUIDE-IT (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) study is designed to determine the safety, efficacy, and cost-effectiveness of a strategy of adjusting therapy with the goal of achieving and maintaining a target N-terminal pro-B-type natriuretic peptide (NT-proBNP) level of <1,000 pg/ml compared with usual care in high-risk patients with systolic heart failure (HF). BACKGROUND: Elevations in natriuretic peptide (NP) levels provide key prognostic information in patients with HF. Therapies proven to improve outcomes in patients with HF are generally associated with decreasing levels of NPs, and observational data show that decreases in NP levels over time are associated with favorable outcomes. Results from smaller prospective, randomized studies of this strategy thus far have been mixed, and current guidelines do not recommend serial measurement of NP levels to guide therapy in patients with HF. METHODS: GUIDE-IT is a prospective, randomized, controlled, unblinded, multicenter clinical trial designed to randomize approximately 1,100 high-risk subjects with systolic HF (left ventricular ejection fraction ≤40%) to eitherusual care (optimized guideline-recommended therapy) or a strategy of adjusting therapy with the goal of achieving and maintaining a target NT-proBNP level of <1,000 pg/ml. Patients in either arm of the study are followed up at regular intervals and after treatment adjustments for a minimum of 12 months. The primary endpoint of the study is time to cardiovascular death or first hospitalization for HF. Secondary endpoints include time to cardiovascular death and all-cause mortality, cumulative mortality, health-related quality of life, resource use, cost-effectiveness, and safety. CONCLUSIONS: The GUIDE-IT study is designed to definitively assess the effects of an NP-guided strategy in high-risk patients with systolic HF on clinically relevant endpoints of mortality, hospitalization, quality of life, and medical resource use. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure [GUIDE-IT]; NCT01685840).
RCT Entities:
OBJECTIVES: The GUIDE-IT (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) study is designed to determine the safety, efficacy, and cost-effectiveness of a strategy of adjusting therapy with the goal of achieving and maintaining a target N-terminal pro-B-type natriuretic peptide (NT-proBNP) level of <1,000 pg/ml compared with usual care in high-risk patients with systolic heart failure (HF). BACKGROUND: Elevations in natriuretic peptide (NP) levels provide key prognostic information in patients with HF. Therapies proven to improve outcomes in patients with HF are generally associated with decreasing levels of NPs, and observational data show that decreases in NP levels over time are associated with favorable outcomes. Results from smaller prospective, randomized studies of this strategy thus far have been mixed, and current guidelines do not recommend serial measurement of NP levels to guide therapy in patients with HF. METHODS: GUIDE-IT is a prospective, randomized, controlled, unblinded, multicenter clinical trial designed to randomize approximately 1,100 high-risk subjects with systolic HF (left ventricular ejection fraction ≤40%) to either usual care (optimized guideline-recommended therapy) or a strategy of adjusting therapy with the goal of achieving and maintaining a target NT-proBNP level of <1,000 pg/ml. Patients in either arm of the study are followed up at regular intervals and after treatment adjustments for a minimum of 12 months. The primary endpoint of the study is time to cardiovascular death or first hospitalization for HF. Secondary endpoints include time to cardiovascular death and all-cause mortality, cumulative mortality, health-related quality of life, resource use, cost-effectiveness, and safety. CONCLUSIONS: The GUIDE-IT study is designed to definitively assess the effects of an NP-guided strategy in high-risk patients with systolic HF on clinically relevant endpoints of mortality, hospitalization, quality of life, and medical resource use. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure [GUIDE-IT]; NCT01685840).
Authors: Douglas S Lee; Muhammad M Mamdani; Peter C Austin; Yanyan Gong; Peter P Liu; Jean L Rouleau; Jack V Tu Journal: Am J Med Date: 2004-05-01 Impact factor: 4.965
Authors: Clyde W Yancy; Mariell Jessup; Biykem Bozkurt; Javed Butler; Donald E Casey; Mark H Drazner; Gregg C Fonarow; Stephen A Geraci; Tamara Horwich; James L Januzzi; Maryl R Johnson; Edward K Kasper; Wayne C Levy; Frederick A Masoudi; Patrick E McBride; John J V McMurray; Judith E Mitchell; Pamela N Peterson; Barbara Riegel; Flora Sam; Lynne W Stevenson; W H Wilson Tang; Emily J Tsai; Bruce L Wilkoff Journal: J Am Coll Cardiol Date: 2013-06-05 Impact factor: 24.094
Authors: Inder S Anand; Lloyd D Fisher; Yann-Tong Chiang; Roberto Latini; Serge Masson; Aldo P Maggioni; Robert D Glazer; Gianni Tognoni; Jay N Cohn Journal: Circulation Date: 2003-03-11 Impact factor: 29.690
Authors: R S McKelvie; S Yusuf; D Pericak; A Avezum; R J Burns; J Probstfield; R T Tsuyuki; M White; J Rouleau; R Latini; A Maggioni; J Young; J Pogue Journal: Circulation Date: 1999-09-07 Impact factor: 29.690
Authors: R Peto; M C Pike; P Armitage; N E Breslow; D R Cox; S V Howard; N Mantel; K McPherson; J Peto; P G Smith Journal: Br J Cancer Date: 1976-12 Impact factor: 7.640
Authors: Anupama Vasudevan; Hourossadat Hashemi Jazi; Jane I Won; Timothy Ball; Gautam R Patankar; Syed A Sarmast; Hyun Joon Shin; Peter A McCullough Journal: Proc (Bayl Univ Med Cent) Date: 2017-04
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: Stephen J Greene; Gregg C Fonarow; Scott D Solomon; Haris P Subacius; Andrew P Ambrosy; Muthiah Vaduganathan; Aldo P Maggioni; Michael Böhm; Eldrin F Lewis; Faiez Zannad; Javed Butler; Mihai Gheorghiade Journal: Eur J Heart Fail Date: 2016-10-17 Impact factor: 15.534
Authors: G Michael Felker; Kevin J Anstrom; Kirkwood F Adams; Justin A Ezekowitz; Mona Fiuzat; Nancy Houston-Miller; James L Januzzi; Daniel B Mark; Ileana L Piña; Gayle Passmore; David J Whellan; Hongqiu Yang; Lawton S Cooper; Eric S Leifer; Patrice Desvigne-Nickens; Christopher M O'Connor Journal: JAMA Date: 2017-08-22 Impact factor: 56.272