Clinical trial NCT05017077: Home Monitoring in Pediatric Heart Failure
Official title: Home Telemonitoring in Pediatric Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Heart Failure
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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)

Primary outcomes:
measure: Primary outcome
timeFrame: three months
Secondary outcomes:
measure: Number of hours of patch kept applied
timeFrame: at 1 week
measure: Number of hours of patch kept applied
timeFrame: at 3 months
measure: Interquartile Range - median of hours of patch kept applied
timeFrame: at 1 week
measure: Interquartile Range - median of hours of patch kept applied
timeFrame: at 3 months
measure: Number of unplanned hospitalization
timeFrame: 3 months
measure: Number of life treating arrhythmias
timeFrame: 3 months
measure: Mortality
timeFrame: 3 months
measure: Number of unplanned hospital access (day hospital / ambulatory)
timeFrame: 3 months
measure: Comparison to levels of Hemoglobin (g/dL)
timeFrame: 3 months
measure: Comparison to levels of Albumin (g/dL)
timeFrame: 3 months
measure: Comparison to levels of Sodium (mEq/L)
timeFrame: 3 months
measure: Comparison to levels of Potassium (mEq/L)
timeFrame: 3 months
measure: Comparison to levels of Serum Creatinine (mg/dL)
timeFrame: 3 months
measure: Satisfaction questionnaire
timeFrame: 1 week
measure: Satisfaction questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Bambino Gesù Hospital
Study officials:
References: