Key result
SCALE-HF 1 evaluates a composite cardiac scale index to predict worsening HF events.
Why the study?
There is a need for simple, noninvasive solutions to remotely monitor and predict worsening heart failure events.
Does a heart function index derived from a cardiac scale accurately predict worsening HF events compared to simple weight-based algorithms in patients with chronic HF?
Observational (n=300)
Yes
Does a heart function index derived from a cardiac scale accurately predict worsening HF events compared to simple weight-based algorithms in patients with chronic HF?
The SCALE-HF 1 study will develop and evaluate a novel composite index from a cardiac scale to predict worsening heart failure events.
Answers are grounded in this paper and cite their sources.
Cardiac scale congestion index detects more HF events with fewer alerts than weight monitoring; leaves open whether alerts reduce events in prospective trials.
BACKGROUND: There is a need for simple, noninvasive solutions to remotely monitor and predict worsening heart failure (HF) events. SCALE-HF 1 (Surveillance and Alert-Based Multiparameter Monitoring to Reduce Worsening Heart Failure Events) is a prospective, multicenter study that will develop and assess the accuracy of the heart function index-a composite algorithm of noninvasive hemodynamic biomarkers from a cardiac scale-in predicting worsening HF events. METHODS: Approximately 300 patients with chronic HF and recent decompensation will be enrolled in this observational study for model development. Patients will be encouraged to take daily cardiac scale measurements. RESULTS: Approximately 50 HF events, defined as an urgent, unscheduled clinic, emergency department, or hospitalization for worsening HF will be used for model development. The composite index will be developed from hemodynamic biomarkers derived from ECG, ballistocardiogram, and impedance plethysmogram signals measured from the cardiac scale. Biomarkers of interest include weight, peripheral impedance, pulse rate and variability, and estimates of stroke volume, cardiac output, and blood pressure captured through the cardiac scale. The sensitivity, unexplained alert rate, and alerting time of the index in predicting worsening HF events will be evaluated and compared with the performance of simple weight-based rule-of-thumb algorithms (eg, weight increase of 3 lbs in 1 day or 5 lbs in 7 days) that are often used in practice. CONCLUSIONS: SCALE-HF 1 is the first study to develop and evaluate the performance of a composite index derived from noninvasive hemodynamic biomarkers measured from a cardiac scale in predicting worsening HF events. Subsequent studies will validate the heart function index and assess its ability to improve patient outcomes. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04882449.
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Fudim et al. (2023) conducted an observational in Chronic heart failure (n=300). Heart function index (composite algorithm from a cardiac scale) vs. Simple weight-based rule-of-thumb algorithms was evaluated on Worsening heart failure events (urgent, unscheduled clinic, emergency department, or hospitalization). The SCALE-HF 1 study is designed to develop and evaluate a composite heart function index from a cardiac scale to predict worsening heart failure events in approximately 300 patients.
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