Author(s): Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K,
Abstract Share this page
Abstract BACKGROUND: This study was designed to determine whether physician-led remote telemedical management (RTM) compared with usual care would result in reduced mortality in ambulatory patients with chronic heart failure (HF). METHODS AND RESULTS: We enrolled 710 stable chronic HF patients in New York Heart Association functional class II or III with a left ventricular ejection fraction ≤35\% and a history of HF decompensation within the previous 2 years or with a left ventricular ejection fraction ≤25\%. Patients were randomly assigned (1:1) to RTM or usual care. Remote telemedical management used portable devices for ECG, blood pressure, and body weight measurements connected to a personal digital assistant that sent automated encrypted transmission via cell phones to the telemedical centers. The primary end point was death from any cause. The first secondary end point was a composite of cardiovascular death and hospitalization for HF. Baseline characteristics were similar between the RTM (n=354) and control (n=356) groups. Of the patients assigned to RTM, 287 (81\%) were at least 70\% compliant with daily data transfers and no break for >30 days (except during hospitalizations). The median follow-up was 26 months (minimum 12), and was 99.9\% complete. Compared with usual care, RTM had no significant effect on all-cause mortality (hazard ratio, 0.97; 95\% confidence interval, 0.67 to 1.41; P=0.87) or on cardiovascular death or HF hospitalization (hazard ratio, 0.89; 95\% confidence interval, 0.67 to 1.19; P=0.44). CONCLUSIONS: In ambulatory patients with chronic HF, RTM compared with usual care was not associated with a reduction in all-cause mortality. CLINICAL TRIAL REGISTRATION: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT00543881.
This article was published in Circulation
and referenced in Journal of Gerontology & Geriatric Research