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

G. Michael Felker, Tariq Ahmad, Kevin J. Anstrom, Kirkwood F. Adams, Lawton S. Cooper, Justin A. Ezekowitz, Mona Fiuzat, Nancy Houston-Miller, James L. Januzzi, Eric S. Leifer, Daniel B. Mark, Patrice Desvigne-Nickens, Gayle Paynter, Ileana L. Pina, David J. Whellan, Christopher M. O'Connor

Research output: Contribution to journalArticle

82 Citations (Scopus)

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 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).

Original languageEnglish (US)
Pages (from-to)457-465
Number of pages9
JournalJACC: Heart Failure
Volume2
Issue number5
DOIs
StatePublished - Oct 1 2014

Fingerprint

Heart Failure
Biomarkers
Natriuretic Peptides
Systolic Heart Failure
Therapeutics
Brain Natriuretic Peptide
Cost-Benefit Analysis
Mortality
Hospitalization
Quality of Life
Guidelines
Safety
Multicenter Studies
Cause of Death
Clinical Trials
Prospective Studies

Keywords

  • biomarkers
  • clinical trial
  • heart failure

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Felker, G. M., Ahmad, T., Anstrom, K. J., Adams, K. F., Cooper, L. S., Ezekowitz, J. A., ... O'Connor, C. M. (2014). Rationale and design of the GUIDE-IT study: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure. JACC: Heart Failure, 2(5), 457-465. https://doi.org/10.1016/j.jchf.2014.05.007

Rationale and design of the GUIDE-IT study : Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure. / 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; Pina, Ileana L.; Whellan, David J.; O'Connor, Christopher M.

In: JACC: Heart Failure, Vol. 2, No. 5, 01.10.2014, p. 457-465.

Research output: Contribution to journalArticle

Felker, GM, Ahmad, T, Anstrom, KJ, Adams, KF, Cooper, LS, Ezekowitz, JA, Fiuzat, M, Houston-Miller, N, Januzzi, JL, Leifer, ES, Mark, DB, Desvigne-Nickens, P, Paynter, G, Pina, IL, Whellan, DJ & O'Connor, CM 2014, 'Rationale and design of the GUIDE-IT study: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure', JACC: Heart Failure, vol. 2, no. 5, pp. 457-465. https://doi.org/10.1016/j.jchf.2014.05.007
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 ; Pina, Ileana L. ; Whellan, David J. ; O'Connor, Christopher M. / Rationale and design of the GUIDE-IT study : Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure. In: JACC: Heart Failure. 2014 ; Vol. 2, No. 5. pp. 457-465.
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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 - Pina, Ileana L.

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N2 - 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).

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