Pediatric Heart FailureHOPE-HFNCT05017077
Home Monitoring in Pediatric Heart Failure
A study testing DynaVision System in people with Pediatric Heart Failure, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pediatric Heart Failure
- What is being tested?
- DynaVision System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- PMK or ICD
- hospitalized patients
- neurological or psychiatric impairment
- urgent waiting list for heart transplantation (UNOS 1A)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pediatric Heart Failure
- Being tested
- DynaVision System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynaVision SystemDevice
Telemonitoring for pediatric heart failure
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring | Experimental | 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 Receives: Device: DynaVision System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three months
Secondary outcomes (15)
Number of hours of patch kept applied
Tolerability
Measured: at 1 week
Number of hours of patch kept applied
Tolerability
Measured: at 3 months
Interquartile Range - median of hours of patch kept applied
Tolerability
Measured: at 1 week
Interquartile Range - median of hours of patch kept applied
Tolerability
Measured: at 3 months
Number of unplanned hospitalization
Reliability
Measured: 3 months
Number of life treating arrhythmias
Reliability
Measured: 3 months
Mortality
Reliability
Measured: 3 months
Number of unplanned hospital access (day hospital / ambulatory)
Reliability
Measured: 3 months
Comparison to levels of Hemoglobin (g/dL)
Reliability
Measured: 3 months
Comparison to levels of Albumin (g/dL)
Reliability
Measured: 3 months
Comparison to levels of Sodium (mEq/L)
Reliability
Measured: 3 months
Comparison to levels of Potassium (mEq/L)
Reliability
Measured: 3 months
Comparison to levels of Serum Creatinine (mg/dL)
Reliability
Measured: 3 months
Satisfaction questionnaire
Satisfaction
Measured: 1 week
Satisfaction questionnaire
Satisfaction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachele Adorisio, Bambino Gesù Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017077
- Sponsor's protocol ID
- 2240_OPBG_2020
- Acronym
- HOPE-HF
- Status last verified
- Aug 2021
- First submitted
- 11 Mar 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Telemonitoring in Pediatric Heart Failure
- ClinicalTrials.gov ID
- NCT05017077
- Acronym / sponsor ID
- HOPE-HF / 2240_OPBG_2020
- Conditions
- Pediatric Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | Experimental | Device: DynaVision SystemTo 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 |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- PMK or ICD
- hospitalized patients
- neurological or psychiatric impairment
- urgent waiting list for heart transplantation (UNOS 1A)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DynaVision SystemTelemonitoring for pediatric heart failure | Device | Telemonitoring |
Primary outcome
Primary outcome
Time frame: three months
number of day (percentage) of adherence to telemonitoring, at least 18 hours per day when the patient kept the patch applied at 3 months.
15 secondary outcomes
Number of hours of patch kept applied
Time frame: at 1 week
Number of hours of patch kept applied
Time frame: at 3 months
Interquartile Range - median of hours of patch kept applied
Time frame: at 1 week
Interquartile Range - median of hours of patch kept applied
Time frame: at 3 months
Number of unplanned hospitalization
Time frame: 3 months
Number of life treating arrhythmias
Time frame: 3 months
Mortality
Time frame: 3 months
Number of unplanned hospital access (day hospital / ambulatory)
Time frame: 3 months
Comparison to levels of Hemoglobin (g/dL)
Time frame: 3 months
Comparison to levels of Albumin (g/dL)
Time frame: 3 months
Comparison to levels of Sodium (mEq/L)
Time frame: 3 months
Comparison to levels of Potassium (mEq/L)
Time frame: 3 months
Comparison to levels of Serum Creatinine (mg/dL)
Time frame: 3 months
Satisfaction questionnaire
Time frame: 1 week
Satisfaction questionnaire
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DynaVision System in people with Pediatric Heart Failure, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.