NCT05708846Completed
Improvement of a Digital Health Platform for Remote Monitoring of Patients With Heart Failure
Observational Study for the Improvement of a Digital Health Platform for Remote Monitoring of Patients With Heart Failure
Source: ClinicalTrials.gov · Last updated 9 Apr 2025
Brief summary (registry, in English)
In the present project, we propose to run an observational study in order to create a huge dataset with telemonitoring data from heart failure (HF) patients. The dataset will contain physiological measurements, socio-demographic data, risk factor information, medication tracking, symptomatology, clinical events and health-related questionnaire answers from each patient. Furthermore, health-related alarms will be delivered to the medical professionals whenever a measure from a patient is out of a predefined clinical range. These alarms and its defined level of relevance (indicated by the medical professionals) will also be Included in the dataset. With the annotated dataset we will be able to implement and train Machine Learning (ML) models that will improve the alarm-based system by making it more robust, trustworthy and reliable.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 154 (actual)
- First submitted
- 13 Jan 2023
- Start date
- 18 May 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- humanITcare
- Diseases
- Heart failure
- NCT number
- NCT05708846
What you commit to
- Study type: Observational
- Participants enrolled: 154
- From 18 May 2023 to the primary completion date, 31 Dec 2024
- 7 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Oncology patients with metastasis or with chemotherapy treatment ongoing
Other illness
- Patients with moderate or severe cognitive impairment without a competent caregiver
- Patients with serious psychiatric illness
- Patients with planned cardiac surgery
- Patients with planned heart transplantation or LVAD implant
Other
- Patients participating in other studies or trials.
- Patients not willing to participate.
- Patients over 150 kg
- Patients who do not use Catalan, Spanish, English, Portuguese, Italian, Dutch, German, Swedish, Hungarian, Romanian or French.
- Patients without a mobile phone
- Patients without internet connexion
Who the study is looking for
- Heart failure (HF) patients with NYHA Functional Class \>= II (according to 2021 EU guidelines).
- Patients older than 18 years old.
- Patients who have suffered an acute decompensation of HF (first and recurrent) in the 30 days prior to enrollment in the study.
- NT-pro BNP ≥300 pg/ml at the moment of hospitalization for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter, NT-pro BNP must be ≥600 pg/mL
- Patients must have had an echocardiogram during their HF hospitalization or in the previous 12 months.
- Prior to initiating any procedures, the hospital will ensure that the patient obtains an informed consent document, if applicable.
- All patients will be eligible regardless of the level of LVEF: HFrEF, HFmrEF, and HFpEF.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Figueres Coordinator of this site? Confirm its status | Figueres | Spain | Unknown status |
| Hospital Universitari de Girona Doctor Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
| Hospital General Universitario Nuestra Señora del Prado Coordinator of this site? Confirm its status | Talavera de la Reina | Spain | Unknown status |
| Hospital Universitario de Torrevieja Coordinator of this site? Confirm its status | Torrevieja | Spain | Unknown status |
| Colentina Hospital Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Hospital Floreasca Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Hospital of Galati Coordinator of this site? Confirm its status | Galati | Romania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.