Rationale and Design of a Pharmacist-led Intervention for the Risk-Based Prevention of Heart Failure: The FIT-HF Pilot Study

Michael C. Wang; Bridget Dolan; Benjamin H. Freed; Lourdes Vega; Nikola Markoski; Amy E. Wainright; Bonnie Kane; Laura E. Seegmiller; Katharine Harrington; Alana A. Lewis; Sanjiv J. Shah; Clyde W. Yancy; Ian J. Neeland; Hongyan Ning; Donald M. Lloyd-Jones; Sadiya S. Khan

doi:10.3389/fcvm.2021.785109

Rationale and Design of a Pharmacist-led Intervention for the Risk-Based Prevention of Heart Failure: The FIT-HF Pilot Study

Michael C. Wang, Bridget Dolan, Benjamin H. Freed, Lourdes Vega, Nikola Markoski, Amy E. Wainright, Bonnie Kane, Laura E. Seegmiller, Katharine Harrington, Alana A. Lewis, Sanjiv J. Shah, Clyde W. Yancy, Ian J. Neeland, Hongyan Ning, Donald M. Lloyd-Jones, Sadiya S. Khan^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

Abstract

Background: Given rising morbidity, mortality, and costs due to heart failure (HF), new approaches for prevention are needed. A quantitative risk-based strategy, in line with established guidelines for atherosclerotic cardiovascular disease prevention, may efficiently select patients most likely to benefit from intensification of preventive care, but a risk-based strategy has not yet been applied to HF prevention. Methods and Results: The Feasibility of the Implementation of Tools for Heart Failure Risk Prediction (FIT-HF) pilot study will enroll 100 participants free of cardiovascular disease who receive primary care at a single integrated health system and have a 10-year predicted risk of HF of ≥5% based on the previously validated Pooled Cohort equations to Prevent Heart Failure. All participants will complete a health and lifestyle questionnaire and undergo cardiac biomarker (B-type natriuretic peptide [BNP] and high-sensitivity cardiac troponin I [hs-cTn]) and echocardiography screening at baseline and 1-year follow-up. Participants will be randomized 1:1 to either a pharmacist-led intervention or usual care for 1 year. Participants in the intervention arm will undergo consultation with a pharmacist operating under a collaborative practice agreement with a supervising cardiologist. The pharmacist will perform lifestyle counseling and recommend initiation or intensification of therapies to optimize risk factor (hypertension, diabetes, and cholesterol) management according to the most recent clinical practice guidelines. The primary outcome is change in BNP at 1-year, and secondary and exploratory outcomes include changes in hs-cTn, risk factor levels, and cardiac mechanics at follow-up. Feasibility will be examined by monitoring retention rates. Conclusions: The FIT-HF pilot study will offer insight into the feasibility of a strategy of quantitative risk-based enrollment into a pharmacist-led prevention program to reduce heart failure risk. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04684264

Original language	English (US)
Article number	785109
Journal	Frontiers in Cardiovascular Medicine
Volume	8
DOIs	https://doi.org/10.3389/fcvm.2021.785109
State	Published - 2021

Funding

Supported by grants from the American Heart Association (#19TPA34890060) and National Institutes of Health (P30DK092939 and P30AG059988) to SSK. The funding sponsor did not contribute to design and conduct of the study, collection, management, analysis, or interpretation of the data or preparation, review, or approval of the manuscript.

Keywords

heart failure
natriuretic peptides
pharmacist
primary prevention
risk prediction

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.3389/fcvm.2021.785109

Cite this

Wang, M. C., Dolan, B., Freed, B. H., Vega, L., Markoski, N., Wainright, A. E., Kane, B., Seegmiller, L. E., Harrington, K., Lewis, A. A., Shah, S. J., Yancy, C. W., Neeland, I. J., Ning, H., Lloyd-Jones, D. M., & Khan, S. S. (2021). Rationale and Design of a Pharmacist-led Intervention for the Risk-Based Prevention of Heart Failure: The FIT-HF Pilot Study. Frontiers in Cardiovascular Medicine, 8, Article 785109. https://doi.org/10.3389/fcvm.2021.785109

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title = "Rationale and Design of a Pharmacist-led Intervention for the Risk-Based Prevention of Heart Failure: The FIT-HF Pilot Study",

abstract = "Background: Given rising morbidity, mortality, and costs due to heart failure (HF), new approaches for prevention are needed. A quantitative risk-based strategy, in line with established guidelines for atherosclerotic cardiovascular disease prevention, may efficiently select patients most likely to benefit from intensification of preventive care, but a risk-based strategy has not yet been applied to HF prevention. Methods and Results: The Feasibility of the Implementation of Tools for Heart Failure Risk Prediction (FIT-HF) pilot study will enroll 100 participants free of cardiovascular disease who receive primary care at a single integrated health system and have a 10-year predicted risk of HF of ≥5% based on the previously validated Pooled Cohort equations to Prevent Heart Failure. All participants will complete a health and lifestyle questionnaire and undergo cardiac biomarker (B-type natriuretic peptide [BNP] and high-sensitivity cardiac troponin I [hs-cTn]) and echocardiography screening at baseline and 1-year follow-up. Participants will be randomized 1:1 to either a pharmacist-led intervention or usual care for 1 year. Participants in the intervention arm will undergo consultation with a pharmacist operating under a collaborative practice agreement with a supervising cardiologist. The pharmacist will perform lifestyle counseling and recommend initiation or intensification of therapies to optimize risk factor (hypertension, diabetes, and cholesterol) management according to the most recent clinical practice guidelines. The primary outcome is change in BNP at 1-year, and secondary and exploratory outcomes include changes in hs-cTn, risk factor levels, and cardiac mechanics at follow-up. Feasibility will be examined by monitoring retention rates. Conclusions: The FIT-HF pilot study will offer insight into the feasibility of a strategy of quantitative risk-based enrollment into a pharmacist-led prevention program to reduce heart failure risk. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04684264",

keywords = "heart failure, natriuretic peptides, pharmacist, primary prevention, risk prediction",

author = "Wang, {Michael C.} and Bridget Dolan and Freed, {Benjamin H.} and Lourdes Vega and Nikola Markoski and Wainright, {Amy E.} and Bonnie Kane and Seegmiller, {Laura E.} and Katharine Harrington and Lewis, {Alana A.} and Shah, {Sanjiv J.} and Yancy, {Clyde W.} and Neeland, {Ian J.} and Hongyan Ning and Lloyd-Jones, {Donald M.} and Khan, {Sadiya S.}",

note = "Publisher Copyright: Copyright {\textcopyright} 2021 Wang, Dolan, Freed, Vega, Markoski, Wainright, Kane, Seegmiller, Harrington, Lewis, Shah, Yancy, Neeland, Ning, Lloyd-Jones and Khan.",

year = "2021",

doi = "10.3389/fcvm.2021.785109",

language = "English (US)",

volume = "8",

journal = "Frontiers in Cardiovascular Medicine",

issn = "2297-055X",

publisher = "Frontiers Media SA",

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Wang, MC, Dolan, B , Freed, BH, Vega, L, Markoski, N, Wainright, AE, Kane, B, Seegmiller, LE, Harrington, K, Lewis, AA , Shah, SJ , Yancy, CW, Neeland, IJ, Ning, H, Lloyd-Jones, DM & Khan, SS 2021, 'Rationale and Design of a Pharmacist-led Intervention for the Risk-Based Prevention of Heart Failure: The FIT-HF Pilot Study', Frontiers in Cardiovascular Medicine, vol. 8, 785109. https://doi.org/10.3389/fcvm.2021.785109

TY - JOUR

T1 - Rationale and Design of a Pharmacist-led Intervention for the Risk-Based Prevention of Heart Failure

T2 - The FIT-HF Pilot Study

AU - Wang, Michael C.

AU - Dolan, Bridget

AU - Freed, Benjamin H.

AU - Vega, Lourdes

AU - Markoski, Nikola

AU - Wainright, Amy E.

AU - Kane, Bonnie

AU - Seegmiller, Laura E.

AU - Harrington, Katharine

AU - Lewis, Alana A.

AU - Shah, Sanjiv J.

AU - Yancy, Clyde W.

AU - Neeland, Ian J.

AU - Ning, Hongyan

AU - Lloyd-Jones, Donald M.

AU - Khan, Sadiya S.

PY - 2021

Y1 - 2021

N2 - Background: Given rising morbidity, mortality, and costs due to heart failure (HF), new approaches for prevention are needed. A quantitative risk-based strategy, in line with established guidelines for atherosclerotic cardiovascular disease prevention, may efficiently select patients most likely to benefit from intensification of preventive care, but a risk-based strategy has not yet been applied to HF prevention. Methods and Results: The Feasibility of the Implementation of Tools for Heart Failure Risk Prediction (FIT-HF) pilot study will enroll 100 participants free of cardiovascular disease who receive primary care at a single integrated health system and have a 10-year predicted risk of HF of ≥5% based on the previously validated Pooled Cohort equations to Prevent Heart Failure. All participants will complete a health and lifestyle questionnaire and undergo cardiac biomarker (B-type natriuretic peptide [BNP] and high-sensitivity cardiac troponin I [hs-cTn]) and echocardiography screening at baseline and 1-year follow-up. Participants will be randomized 1:1 to either a pharmacist-led intervention or usual care for 1 year. Participants in the intervention arm will undergo consultation with a pharmacist operating under a collaborative practice agreement with a supervising cardiologist. The pharmacist will perform lifestyle counseling and recommend initiation or intensification of therapies to optimize risk factor (hypertension, diabetes, and cholesterol) management according to the most recent clinical practice guidelines. The primary outcome is change in BNP at 1-year, and secondary and exploratory outcomes include changes in hs-cTn, risk factor levels, and cardiac mechanics at follow-up. Feasibility will be examined by monitoring retention rates. Conclusions: The FIT-HF pilot study will offer insight into the feasibility of a strategy of quantitative risk-based enrollment into a pharmacist-led prevention program to reduce heart failure risk. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04684264

AB - Background: Given rising morbidity, mortality, and costs due to heart failure (HF), new approaches for prevention are needed. A quantitative risk-based strategy, in line with established guidelines for atherosclerotic cardiovascular disease prevention, may efficiently select patients most likely to benefit from intensification of preventive care, but a risk-based strategy has not yet been applied to HF prevention. Methods and Results: The Feasibility of the Implementation of Tools for Heart Failure Risk Prediction (FIT-HF) pilot study will enroll 100 participants free of cardiovascular disease who receive primary care at a single integrated health system and have a 10-year predicted risk of HF of ≥5% based on the previously validated Pooled Cohort equations to Prevent Heart Failure. All participants will complete a health and lifestyle questionnaire and undergo cardiac biomarker (B-type natriuretic peptide [BNP] and high-sensitivity cardiac troponin I [hs-cTn]) and echocardiography screening at baseline and 1-year follow-up. Participants will be randomized 1:1 to either a pharmacist-led intervention or usual care for 1 year. Participants in the intervention arm will undergo consultation with a pharmacist operating under a collaborative practice agreement with a supervising cardiologist. The pharmacist will perform lifestyle counseling and recommend initiation or intensification of therapies to optimize risk factor (hypertension, diabetes, and cholesterol) management according to the most recent clinical practice guidelines. The primary outcome is change in BNP at 1-year, and secondary and exploratory outcomes include changes in hs-cTn, risk factor levels, and cardiac mechanics at follow-up. Feasibility will be examined by monitoring retention rates. Conclusions: The FIT-HF pilot study will offer insight into the feasibility of a strategy of quantitative risk-based enrollment into a pharmacist-led prevention program to reduce heart failure risk. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04684264

KW - heart failure

KW - natriuretic peptides

KW - pharmacist

KW - primary prevention

KW - risk prediction

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ER -

Rationale and Design of a Pharmacist-led Intervention for the Risk-Based Prevention of Heart Failure: The FIT-HF Pilot Study

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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