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://ichgcp.net/clinical-trials-registry/NCT04684264.

Keywords: heart failure; natriuretic peptides; pharmacist; primary prevention; risk prediction.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Wang, Dolan, Freed, Vega, Markoski, Wainright, Kane, Seegmiller, Harrington, Lewis, Shah, Yancy, Neeland, Ning, Lloyd-Jones and Khan.

Figures

Figure 1

Overview of the FIT-HF study. Participants will be recruited by invitation from the eligible study population using an electronic health record-based report. They will complete eConsent and questionnaires online and have biomarkers measured and echocardiograms performed at baseline and 1 year. In the interim, they will be randomized 1:1 to a pharmacist-led intervention or to usual care. HF represents heart failure; EDW Enterprise Data Warehouse. Created with BioRender.com.

Figure 2

Pharmacist-directed intervention treatment algorithm. The treatment algorithm was derived from professional society guidelines for the primary prevention of cardiovascular disease as well as blood pressure, glucose, and lipid lowering. Special consideration is given to the early initiation of SGLT-2 inhibitors in patients with diabetes, given the evidence supporting their efficacy in heart failure prevention and current guideline recommendations. BP represents blood pressure; ACEi angiotensin converting enzyme inhibitor; ARB angiotensin receptor blocker; CCB calcium channel blocker; SMBG self-monitored blood glucose; eGFR estimated glomerular filtration rate; PCP primary care physician; DM diabetes mellitus; SBP systolic blood pressure; DBP diastolic blood pressure; HTN hypertension.