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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Italy1 site
  • Bambino Gesù Hospital

    Rome, 00165

Other trials in Italy

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.

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 groups in NCT05017077
Study groupRoleWhat they receive
TelemonitoringExperimentalTo 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.

  1. 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)
  1. Number of hours of patch kept applied

    Tolerability

    Measured: at 1 week

  2. Number of hours of patch kept applied

    Tolerability

    Measured: at 3 months

  3. Interquartile Range - median of hours of patch kept applied

    Tolerability

    Measured: at 1 week

  4. Interquartile Range - median of hours of patch kept applied

    Tolerability

    Measured: at 3 months

  5. Number of unplanned hospitalization

    Reliability

    Measured: 3 months

  6. Number of life treating arrhythmias

    Reliability

    Measured: 3 months

  7. Mortality

    Reliability

    Measured: 3 months

  8. Number of unplanned hospital access (day hospital / ambulatory)

    Reliability

    Measured: 3 months

  9. Comparison to levels of Hemoglobin (g/dL)

    Reliability

    Measured: 3 months

  10. Comparison to levels of Albumin (g/dL)

    Reliability

    Measured: 3 months

  11. Comparison to levels of Sodium (mEq/L)

    Reliability

    Measured: 3 months

  12. Comparison to levels of Potassium (mEq/L)

    Reliability

    Measured: 3 months

  13. Comparison to levels of Serum Creatinine (mg/dL)

    Reliability

    Measured: 3 months

  14. Satisfaction questionnaire

    Satisfaction

    Measured: 1 week

  15. 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.

  1. First posted23 Aug 2021
  2. Study start1 Sep 2021 (estimated)
  3. Primary completion1 Apr 2022 (estimated)
  4. Study completion1 Apr 2023 (estimated)

Resources

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)
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

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.

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