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Published on: April 19, 2019
Feasibility of the Implementation of Tools for Heart Failure Risk Prediction: A Randomized Controlled Pilot Trial
Michael C Wang1, Bridget Dolan2, Xiaoning Huang3
1Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Insights
This pilot study shows that risk-based heart failure (HF) prevention is feasible. While B-type natriuretic peptide levels did not significantly change, high-sensitivity cardiac troponin I levels decreased in the intervention group.
Area of Science:
- Cardiology
- Preventive Medicine
- Clinical Trials
Background:
- The 2022 ACC/AHA guidelines advocate for multivariable risk equations in heart failure (HF) prevention.
- Prospective assessment of this risk-based strategy for HF prevention was lacking.
Purpose of the Study:
- To determine the feasibility of implementing risk-based strategies for preventing heart failure.
- To evaluate the impact of a collaborative care model with a pharmacist on HF risk markers.
Main Methods:
- The Feasibility of the Implementation of Tools for Heart Failure Risk Prediction (FIT-HF) study was a randomized controlled pilot trial.
- Patients with a predicted 10-year HF risk ≥5% were randomized to usual care or collaborative care with a pharmacist.
- Biomarkers (BNP, hs-cTn) and echocardiography were assessed at baseline and 1-year follow-up.
Main Results:
- 82 participants completed the 1-year follow-up.
- The intervention group showed a statistically significant reduction in high-sensitivity cardiac troponin I (hs-cTn) levels (-1.8, P=0.03).
- No significant difference was observed in the primary outcome, B-type natriuretic peptide (BNP) levels, between groups (P=0.13).
Conclusions:
- The FIT-HF study confirms the feasibility of enrolling patients for risk-based HF prevention using predicted risk scores.
- Larger trials are necessary to establish the efficacy and long-term effects of these preventive interventions.
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).
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