TY - JOUR
T1 - Rationale and design of theguide-it study
T2 - Guiding evidence based therapy usingbiomarker intensified treatment inheart failure
AU - Felker, G. Michael
AU - Ahmad, Tariq
AU - Anstrom, Kevin J.
AU - Adams, Kirkwood F.
AU - Cooper, Lawton S.
AU - Ezekowitz, Justin A.
AU - Fiuzat, Mona
AU - Houston-Miller, Nancy
AU - Januzzi, James L.
AU - Leifer, Eric S.
AU - Mark, Daniel B.
AU - Desvigne-Nickens, Patrice
AU - Paynter, Gayle
AU - Piña, Ileana L.
AU - Whellan, David J.
AU - O'Connor, Christopher M.
N1 - Publisher Copyright:
© 2014 American College of Cardiology Foundation.
PY - 2014/10/1
Y1 - 2014/10/1
N2 - 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 resourceuse. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure [GUIDE-IT]; NCT01685840).
AB - 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 resourceuse. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure [GUIDE-IT]; NCT01685840).
KW - Biomarkers
KW - Clinical trial
KW - Heart failure
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UR - http://www.scopus.com/inward/citedby.url?scp=84908060979&partnerID=8YFLogxK
U2 - 10.1016/j.jchf.2014.05.007
DO - 10.1016/j.jchf.2014.05.007
M3 - Article
C2 - 25194287
AN - SCOPUS:84908060979
SN - 2213-1779
VL - 2
SP - 458
EP - 465
JO - JACC: Heart Failure
JF - JACC: Heart Failure
IS - 5
ER -