Feasibility of the Implementation of Tools for Heart Failure Risk Prediction (FIT-HF)

Transforming the Primary Prevention Paradigm for Heart Failure: Feasibility of the Implementation of Tools for Heart Failure Risk Prediction

The purpose of this study is to gather information to develop a heart failure screening and prevention program.

All participants will undergo phlebotomy for specimen collection (BNP, hs-cTn, BMP and lipid testing, biorepository storage) and baseline echocardiography. All participants will additionally be administered a health and lifestyle questionnaire, undergo measurement of vital signs, and receive uniform education on heart-healthy lifestyle and signs and symptoms of heart failure. Participants who are randomized to the intervention arm will receive a referral to Heart Failure Prevention Clinic, a pharmacist-directed practice in collaboration with an attending cardiologist, where they will be followed for 1 year, with their primary care physician updated after each visit. The information from their BNP, hs-cTn, and echocardiography will be provided to them and their primary care physicians as well as the pharmacist and cardiologist team members. The participants (and their primary care providers) who are randomized to usual care will be blinded to their BNP and hs-cTn values and echocardiography results.

Participants will be referred to a pharmacist-directed collaborative practice for heart failure prevention.

Heart Failure Prevention Clinic is a pharmacist-directed practice in collaboration with an attending cardiologist that uses evidence-based guidelines to optimize medications and lifestyle interventions for heart failure prevention.

All participants will have brain natriuretic peptide (BNP) measured at baseline and at 1-year follow-up.

All participants will have high sensitivity cardiac troponin (hs-cTn) measured at baseline and at 1-year follow-up.

All participants will have systolic blood pressure and diastolic blood pressure measured at baseline and at 1-year follow-up.

All participants will have estimated glomerular filtration rate measured at baseline and at 1-year follow-up.

All participants will be asked about smoking status at baseline and at 1-year follow-up. Outcome is, among patients who were current smokers at baseline, quit attempt or no smoking at 1 year.

All participants will be asked about adherence to medications (if applicable) using questions of nonadherence from the Atherosclerosis Risk in Communities study.

All participants will have biorepository storage of serum and plasma at baseline. An exploratory analysis will use a commercial biomarker array to investigate correlations with echocardiogram, BNP, and hs-cTn results.

All participants will be asked about fruit and vegetable intake at baseline and at 1 year. Outcome will be measured in servings/week.

All participants will be asked about salt intake at baseline and at 1 year using a 5-point Likert scale (always, often, sometimes, rarely, never). A higher score on this scale is preferable.

All participants will be asked about physical activity at baseline and at 1 year. Outcome is measured in minutes of moderate-intensity activity per week. Vigorous-intensity activity will count as twice the equivalent duration of moderate-intensity activity.

All participants will be asked about sedentary behavior at baseline and at 1 year. Outcome is measured in minutes of sedentary behavior per day.

Health utility will be measured by the EurolQol 5 Dimensions 5 Levels (EQ-5D-5L) instrument. Typical scores range from 0 to 1, with 1 being ideal health-related quality of life.

Overall health will be measured by the EurolQol Visual Analog Scale (EQ VAS) instrument. Scores range from 0-100, with 100 being the highest overall health.

Inclusion Criteria: 10-year risk of heart failure >5% based on the PCP-HF equations At least one primary care visit in the last 12 months At least one additional primary care visit in the last 5 years Had cholesterol and glucose checked within the past 5 years Exclusion Criteria: History of cardiovascular disease Signs and symptoms of heart failure Estimated glomerular filtration rate <45 mL/min/1.73m^2 Stage 3 or 4 cancer Pregnancy

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. Rationale and Design of a Pharmacist-led Intervention for the Risk-Based Prevention of Heart Failure: The FIT-HF Pilot Study. Front Cardiovasc Med. 2021 Nov 29;8:785109. doi: 10.3389/fcvm.2021.785109. eCollection 2021. Erratum In: Front Cardiovasc Med. 2022 Feb 18;9:844270.