Home Monitoring in Pediatric Heart Failure

NCT ID: NCT05017077

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-04-01

Brief Summary

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.

Conditions

Pediatric Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

DynaVision System

Intervention Type: DEVICE

Telemonitoring for pediatric heart failure

Interventions

DynaVision System

Telemonitoring for pediatric heart failure

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bambino Gesù Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Rachele Adorisio

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bambino Gesù Hospital

Rome, , Italy

Countries

Italy

Other Identifiers

2240_OPBG_2020

Identifier Type: -

Identifier Source: org_study_id