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
Highlights
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
Advances in the prevention of ischemic heart disease have been offset by increasing mortality related to heart failure (HF), resulting in stagnation in overall cardiovascular disease mortality rates since 2011 [3]
Summary
Mortality, and costs due to heart failure (HF), new approaches for prevention are needed. Overall cardiovascular disease mortality has declined 3fold over the past five decades [1], this has been largely driven by improvement in ischemic heart disease mortality rates [2]. Advances in the prevention of ischemic heart disease have been offset by increasing mortality related to heart failure (HF), resulting in stagnation in overall cardiovascular disease mortality rates since 2011 [3]. Given the large and rising morbidity, mortality, and costs of HF, evidence-based and generalizable prevention strategies, which currently exist for atherosclerotic cardiovascular disease (ASCVD) [5] but not HF, are needed. Two important questions in the design of a potential HF prevention strategy include [1] how to assess patients’ individual risk for HF and [2] how to intensify prevention efforts in patients identified as high risk.
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