TELEMETRIC-HF: Pilot Randomized Study of Telemetry-Guided Guideline-Directed Medical Therapy Optimization and Ventricular Arrhythmia Surveillance in Patients with Heart Failure with Reduced Ejection Fraction.

PURPOSE: To evaluate the feasibility of telemetry-guided optimization of guideline-directed medical therapy (GDMT) and continuous arrhythmic surveillance in ambulatory patients with heart failure with reduced ejection fraction (HFrEF). METHODS: TELEMETRIC-HF was a single-center, randomized, open-label pilot study including 30 patients with HFrEF assigned to telemetry-guided management (n=15) or standard outpatient care (n=15). Patients in the telemetry group underwent 8 weeks of continuous ambulatory monitoring using the CPC12 CE MDR Class IIb wearable system, providing continuous electrocardiographic and physiological monitoring with clinician oversight. The primary endpoint was the between-group difference in beta-blocker (BB) target-dose achievement at 8 weeks. Secondary endpoints included optimization of other GDMT classes, ventricular arrhythmia detection, clinical status, quality of life, safety, and healthcare utilization. RESULTS: Telemetry-guided management was associated with significantly greater BB target-dose achievement at 8 weeks than standard care (60.0% vs. 39.2% of the guideline-recommended target dose; absolute difference 20.8 percentage points, 95% CI 2.7-39.2; p=0.028). Target-dose achievement for angiotensin receptor-neprilysin inhibitors, mineralocorticoid receptor antagonists, and sodium-glucose cotransporter-2 inhibitors did not differ significantly between groups. Recurrent non-sustained ventricular tachycardia was detected only in the telemetry group, prompting additional clinical evaluation, antiarrhythmic therapy, and primary prevention implantable cardioverter-defibrillator implantation in one patient. Hemodynamic, laboratory, and echocardiographic parameters remained stable throughout follow-up, and telemetry was well tolerated. No heart failure hospitalizations or deaths occurred during the 8-week study period. CONCLUSION: In this pilot randomized study, telemetry-guided remote monitoring was feasible and was associated with earlier BB optimization and improved detection of clinically relevant ventricular arrhythmias without compromising safety. These exploratory findings support further evaluation of telemetry-guided outpatient heart failure management in larger, adequately powered multicenter randomized trials.