Pediatric Heart Failure Clinical Trial
— HOPE-HFOfficial title:
Home Telemonitoring in Pediatric Heart Failure
| Verified date | August 2021 |
| Source | Bambino Gesù Hospital and Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Enrolling by invitation |
| Enrollment | 20 |
| Est. completion date | April 1, 2023 |
| Est. primary completion date | April 1, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Month to 18 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Bambino Gesù Hospital | Rome |
| Lead Sponsor | Collaborator |
|---|---|
| Bambino Gesù Hospital and Research Institute |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Number of hours of patch kept applied | Tolerability | at 1 week | |
| Secondary | Number of hours of patch kept applied | Tolerability | at 3 months | |
| Secondary | Interquartile Range - median of hours of patch kept applied | Tolerability | at 1 week | |
| Secondary | Interquartile Range - median of hours of patch kept applied | Tolerability | at 3 months | |
| Secondary | Number of unplanned hospitalization | Reliability | 3 months | |
| Secondary | Number of life treating arrhythmias | Reliability | 3 months | |
| Secondary | Mortality | Reliability | 3 months | |
| Secondary | Number of unplanned hospital access (day hospital / ambulatory) | Reliability | 3 months | |
| Secondary | Comparison to levels of Hemoglobin (g/dL) | Reliability | 3 months | |
| Secondary | Comparison to levels of Albumin (g/dL) | Reliability | 3 months | |
| Secondary | Comparison to levels of Sodium (mEq/L) | Reliability | 3 months | |
| Secondary | Comparison to levels of Potassium (mEq/L) | Reliability | 3 months | |
| Secondary | Comparison to levels of Serum Creatinine (mg/dL) | Reliability | 3 months | |
| Secondary | Satisfaction questionnaire | Satisfaction | 1 week | |
| Secondary | Satisfaction questionnaire | Satisfaction | 3 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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