Rationale and design of the GUIDE-IT study: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.

Authors

G. Michael Felker, Duke University Medical CenterFollow
Tariq Ahmad, Duke University Medical Center
Kevin J. Anstrom, Duke University Medical CenterFollow
Kirkwood F. Adams, University of North Carolina
Lawton S. Cooper, National Heart, Lung, and Blood InstituteFollow
Justin A. Ezekowitz, University of AlbertaFollow
Mona Fiuzat, Duke University Medical CenterFollow
Nancy Houston-Miller, Stanford University
James L. Januzzi, Massachusetts General Hospital
Eric S. Leifer, National Heart, Lung, and Blood Institute
Daniel B. Mark, Duke University Medical CenterFollow
Patrice Desvigne-Nickens, National Heart, Lung, and Blood Institute
Gayle Paynter, Duke University Medical Center
Ileana L. Piña, Montefiore-Einstein Medical CenterFollow
David J. Whellan, Thomas Jefferson UniversityFollow
Christopher M. O'Connor, Duke University Medical CenterFollow

Document Type

Article

Publication Date

10-1-2014

Comments

This article has been peer reviewed. It is the authors' final version prior to publication in JACC: Heart failure

Volume 2, Issue 5, October 2014, Pages 457-465.

The published version is available at DOI: 10.1016/j.jchf.2014.05.007. Copyright © Elsevier

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

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

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).

Recommended Citation

Felker, G. Michael; Ahmad, Tariq; Anstrom, Kevin J.; Adams, Kirkwood F.; Cooper, Lawton S.; Ezekowitz, Justin A.; Fiuzat, Mona; Houston-Miller, Nancy; Januzzi, James L.; Leifer, Eric S.; Mark, Daniel B.; Desvigne-Nickens, Patrice; Paynter, Gayle; Piña, Ileana L.; Whellan, David J.; and O'Connor, Christopher M., "Rationale and design of the GUIDE-IT study: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure." (2014). Division of Cardiology Faculty Papers. Paper 61.
https://jdc.jefferson.edu/cardiologyfp/61

Creative Commons License

This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.

PubMed ID

25194287