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SELENE HF Clinical Trial

Combining home monitoring temporal trends from implanted defibrillators and baseline patient risk profile to predict heart failure hospitalizations (SELENE HF)

D’Onofrio A et al. Europace 2021
doi: 10.1093/europace/euab170.

Study Design

  • International, multi-center, prospective, observational, event-driven cohort study
  • 34 centers in Italy and Spain
  • 918 ICD and CRT-D patients with NYHA Class II-III, LVEF ≤ 35%
  • To develop an algorithm to predict HF hospitalization based on seven Home Monitoring parameters and a baseline risk stratification (Seattle Heart Failure Model)
  • Home Montoring parameters: Mean heart rate, mean heart rate at rest, premature ventricular contractions (PVC), atrial burden, heart rate variability (HRV), patient activity, and thoracic impedance (TI)
  • Primary endpoint: First HF-related hospitalization
  • Collection of ≥ 50 primary endpoint events
  • Post-hoc randomization into 2 cohorts for algorithm development and validation

Key Result

The algorithm predicted heart failure hospitalizations early, with high sensitivity and with a low false alert rate

Selene AF Key Result 1

Table 1: Main performance parameters of the predicting algorithm

(Numbers in brackets: confidence intervals, except for alerting time (IQR).

Clinical Relevance

  • Heart failure is associated with poor prognosis and high hospitalization rates. Recurrent hospital admission due to heart failure results in a gradual worsening of the health status of patients and constitutes a considerable healthcare burden.
  • Early prevention of HF decompensation is a key strategy to improve patient outcomes. An CIED-based algorithm that predicts impending heart failure hospitalization could help reduce hospitalization among high-risk heart failure patients.

Study Details

Study Objective

  • To develop an algorithm to predict HF hospitalization based on seven Home Monitoring parameters and a baseline risk stratification (Seattle Heart Failure Model)

Primary Endpoint

  • First HF-related hospitalization

Major Secondary Endpoints

  • Any (first or subsequent) hospitalization or death for worsening HF
  • Outpatient intravenous interventions (IVI) for worsening HF

Clinical Sites

  • 34 (Italy, Spain)

Sample Size

  • 918 patients

Main Inclusion Criteria

  • ICD or CRT-D patients LVEF ≤ 35%
  • NYHA class II or III
  • ≥18 years of age

Main Exclusion Criteria

  • Permanent AF
  • Acutely decompensated HF
  • History of stroke
  • Planned cardiac surgery
  • Short life expectancy <6 months
  • Insufficient mobile phone service coverage at home

Study Flowchart

SELENE HF Study Flowchart

Follow-Up

  • The study was event driven. The median follow-up duration was 22.5 months.

Study Duration

  • May 2012 to March 2017

Reference no.

  • NCT01836510

Principal Investigators

  • D’Onofrio A., AORN Azienda Ospedaliera dei Colli Monaldi, Naples, Italy

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