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

Produkty

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