Feasibility of the Implementation of Tools for Heart Failure Risk Prediction: A Randomized Controlled Pilot Trial.

BACKGROUND

The 2022 American College of Cardiology/American Heart Association heart failure (HF) guidelines recommended the use of multivariable risk equations to guide HF prevention. However, this strategy has not been prospectively assessed.

OBJECTIVES

The aim of the study was to determine the feasibility of risk-based prevention of HF.

METHODS

The FIT-HF (Feasibility of the Implementation of Tools for Heart Failure Risk Prediction) study was a randomized controlled pilot trial. Patients with a predicted 10-year HF risk ≥5% were randomly assigned 1:1 to receive either usual care or collaborative care with a pharmacist. All participants underwent B-type natriuretic peptide (BNP) and high-sensitivity cardiac troponin I (hs-cTn) testing and echocardiography at baseline and 1-year follow-up. The primary outcome, change in BNP at 1 year, was examined using linear mixed models. Secondary outcomes included change in hs-cTn and traditional risk factor levels. Exploratory outcomes included echocardiographic measures and lifestyle measures.

RESULTS

Of 101 randomized participants, 82 completed 1-year follow-up and comprised the primary analytic sample. Mean (SD) age was 70.0 (7.0) years, 45% were female, 83% self-identified as White, and mean (SD) predicted 10-year risk of HF was 12.2% (8.0). Baseline mean (SD) BNP (pg/mL) was 40.2 (28.2) and 36.5 (19.6) in the intervention and control arms, respectively. Model-estimated between-arm difference (95% CI) in BNP at 1 year follow-up was -9.0 (-20.6 to 2.6, P = 0.13), and in hs-cTn was -1.8 (-3.5 to -0.2, P = 0.03), favoring the intervention. Differences in other secondary outcomes were not statistically significant.

CONCLUSIONS

FIT-HF demonstrates the feasibility of enrolling patients based on predicted risk for risk-based HF prevention; larger follow-up studies are needed to determine efficacy and long-term impact of specific preventive interventions. (Feasibility of the Implementation of Tools for Heart Failure Risk Prediction [FIT-HF]; NCT04684264).