Simplified non-invasive heart failure monitoring: study design and baseline from the randomized controlled HANSE-STEPS trial

Aims 

Heart failure (HF) is associated with increased mortality, morbidity and less quality of life. HF rehospitalization is the main reason for a progressive decline. Invasive monitoring showed first positive data in early detection and prevention. Data on simplified non-invasive telemonitoring are lacking. 

A single center randomized controlled trial – HANSE-STEPS – compared two arms of HF non-invasive surveillance. One group was monitored by standardized phone calls, the other one telemonitored by step trackers and daily data transfer on a telemedical platform. The primary endpoint was unplanned phone calls or HF visits by the patients. Secondary endpoints were cardiovascular death, HF rehospitalization, quality of life by EQ5D and KCCQ, 6-minute walking distance and guideline-directed medical treatment.

From 2022 to 2024 a total of 200 patients were recruited and randomized at 1:1. Nine patients were crossovers to the phone group due to four allergic reactions on the rubber band, four technical issues and one withdrawal of telemonitoring consent. One year follow-up is ongoing until November 2025.

Baseline characteristics revealed a significantly elder (Phone vs. step tracking: 66.8±15.0 vs. 60.9±14.8 years, p=0.003) and more female population (Phone vs. step tracking: 35 vs 22%, p=0.03) in the telephone group. Typical cardiovascular comorbidities such as coronary artery disease (Phone vs. step tracking: 62 vs. 48%, p=0.037), stroke/transient ischemic attack (Phone vs. step tracking: 22 vs. 8%, p=0.04) and valvular interventions (Phone vs. step tracking: 13 vs 5%, p=0.043) were significantly higher in the telephone group. In addition, the etiology of non-ischemic or dilated cardiomyopathy was less (Phone vs. step tracking: 40 vs. 50%, p=0.032) present. The following phenotypes of heart failure were equally distributed: reduced ejection fraction (HFrEF, Phone vs. step tracking: 65% vs. 74%, p=0.17), improved EF (Phone vs. step tracking: 12% vs. 14%, p=0.9), mildly reduced EF (Phone vs. step tracking: 4% vs. 6%, p=0.8) except for preserved EF (HFpEF, Phone vs. step tracking: 19% vs. 6%, p=0.01). Anemia (Phone vs. step tracking: Hemoglobin, 12.6±2.3 vs. 14.0±2.2 g/dl, p<0.001) and Iron (Phone vs. step tracking: Transferrin saturation 21.0±12.2 vs. 25.5±11.8 %, p=0.03) were significantly higher in the telemonitoring group, renal function (Phone vs. step tracking: 59.7±25.4 vs. 65.0±23.2 ml/min, p=0.13) and N-terminal-proBrain Natriuretic Peptide (Phone vs. step tracking: 5.169.4±9263.0 vs. 4287.5±9622.8 ng/l, p=0.51) showed no significant differences.

This randomized trial of HF telemonitoring provided first insights into the typical ischemic male population with HFrEF. However, there is also evidence in the telephone group was more female and HFpEF patients. The follow-up and endpoint evaluation are ongoing.