Home Monitoring in Pediatric Heart Failure (HOPE-HF)

Home Telemonitoring in Pediatric Heart Failure

Heart failure is a complex clinical syndrome, representing the final evolution of many cardiac diseases that may differ for etiology and pathophysiology. In pediatric population, it is particularly challenging to manage because of the heterogeneity in age, primary cardiac disease, and the broad range of clinical signs and symptoms. Frequent hospitalizations are current problem. Hospitalization within the first year since the first episode, lack of adherence to medical therapy and diet difficulties are the main issues in this population of patients, and they rebounds on prognosis and public health costs. Actions aimed to prevent and manage these matters will improve outcome in patients with chronic heart failure. Telemedicine proved its usefulness in adult population, but, nowadays, no studies have been conducted in children. From the beginning of 21th century, remote monitoring attempts have been adopted, initially by phone calls. Currently, the e-care monitoring fits in the context of telemedicine 2.0 based on new communication models. The aim of this study is to affirm the feasibility and efficacy of a new model of tele monitoring in pediatric population. High-risk patients need a strict clinical control normally difficult to adopt. A telematics system capable to detect vital parameters as heart rate, body temperature, blood pressure, oxygen saturation, breathe frequency, weight, arrhythmias and cardiac index may offers to physician valuable information able to strictly monitoring the clinical status of patients. All of these data permits to physician to early detect critical signals of a deteriorated status, modify adherence to care and implement therapeutic strategies in order to prevent frequent hospitalizations. Our project provides a system of continuous tele-monitoring of vital parameters through a patch applied on the chest of the baby. Data are sent to a service center, "virtual clinic" and daily analyzed in multiparametric system by a specialized nurse. On the basis of pre-established alarms, the virtual clinic will notify to physician. Feasibility and tolerability of this new monitoring system will be evaluated after a 3 months period on a cohort of 20 patients affected by chronic, high-risk, heart failure.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pediatric Heart Failure
• Intervention / Treatment: Device: DynaVision System

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00165
    • Bambino Gesu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• NYHA/Ross class III or IV
• Severe impairment of ventricular function (EF < 40%) both for left or univentricular
• Prior hospitalization for acute heart failure within 1 year
• At least 2 prior hospitalization for acute heart failure
• Patients on waiting list for orthotopic heart transplantation (UNOS 1B,2)
• Informed consent obtained

Exclusion Criteria:

• PMK or ICD
• hospitalized patients
• neurological or psychiatric impairment
• urgent waiting list for heart transplantation (UNOS 1A)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Telemonitoring; To evaluate the feasibility and efficacy of a new model of tele monitoring in pediatric population in advanced heart failure, we will enroll 20 patients in advanced NYHA/Ross class in waiting list for Heart Transplant. An home telemonitoring capable to detect vital parameters as heart rate, body temperature, blood pressure, oxygen saturation, breathe frequency, weight, arrhythmias and cardiac index may offers to physician valuable information able to strictly monitoring the clinical status of patients

Device: DynaVision System; Telemonitoring for pediatric heart failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome	number of day (percentage) of adherence to telemonitoring, at least 18 hours per day when the patient kept the patch applied at 3 months.	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hours of patch kept applied	Tolerability	at 1 week
Number of hours of patch kept applied	Tolerability	at 3 months
Interquartile Range - median of hours of patch kept applied	Tolerability	at 1 week
Interquartile Range - median of hours of patch kept applied	Tolerability	at 3 months
Number of unplanned hospitalization	Reliability	3 months
Number of life treating arrhythmias	Reliability	3 months
Mortality	Reliability	3 months
Number of unplanned hospital access (day hospital / ambulatory)	Reliability	3 months
Comparison to levels of Hemoglobin (g/dL)	Reliability	3 months
Comparison to levels of Albumin (g/dL)	Reliability	3 months
Comparison to levels of Sodium (mEq/L)	Reliability	3 months
Comparison to levels of Potassium (mEq/L)	Reliability	3 months
Comparison to levels of Serum Creatinine (mg/dL)	Reliability	3 months
Satisfaction questionnaire	Satisfaction	1 week
Satisfaction questionnaire	Satisfaction	3 months

Collaborators and Investigators

• Sponsor: Bambino Gesù Hospital and Research Institute

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2021
• Primary Completion (ANTICIPATED): April 1, 2022
• Study Completion (ANTICIPATED): April 1, 2023

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (ACTUAL): August 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2240_OPBG_2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No