NCT05825755Completed
Multicenter Trial for the Validation of Vitalera Platform
Randomized Controlled Multicenter Trial for the Validation of Vitalera Platform
Source: ClinicalTrials.gov · Last updated 19 Mar 2025
Brief summary (registry, in English)
Vitalera has implemented a cloud platform for the telemonitoring of chronic patients through portable medical devices and an alarm-based system that issues health alerts when a patient's biomedical measurement is outside a predefined clinical range. The platform frees doctors and caregivers from reviewing individual patient data for abnormalities, speeding up the decision-making process and reducing hospital visits. With this study we intend to validate the efficacy of the app for patients and digital platform for medical professionals, evaluating the increase in the quality of life of patients and measuring the reduction in the incidence of the main critical events of HF. In addition, the study will validate the new API interoperability standards and platform architecture and will assess the usability of the platform by delivering satisfaction questionnaires to patients and professionals at the end of the study. This study is being carried out within the framework of a European project promoted by the European Innovation Council (EIC).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 97 (actual)
- First submitted
- 24 Mar 2023
- Start date
- 20 Mar 2024
- Primary completion date
- 16 Nov 2024
- Lead sponsor
- humanITcare
- Diseases
- Heart failure
- NCT number
- NCT05825755
What you commit to
- Study type: Interventional
- Participants enrolled: 97
- From 20 Mar 2024 to the primary completion date, 16 Nov 2024
- 10 sites in 1 country
- 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 (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital d'Alcoi Coordinator of this site? Confirm its status | Alcoy | Spain | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Corporació de Salut del Maresme i la Selva (Hospital de Blanes-Hospital de Calella) Coordinator of this site? Confirm its status | Blanes | Spain | Unknown status |
| Hospital De Denia Coordinator of this site? Confirm its status | Denia | Spain | Unknown status |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Unknown status |
| Hospital de Vinalopó Coordinator of this site? Confirm its status | Elche | Spain | Unknown status |
| Hospital Universitari Sant Joan de Reus Coordinator of this site? Confirm its status | Reus | Spain | Unknown status |
| Hospital de Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Unknown status |
| Hospital de Torrejón Coordinator of this site? Confirm its status | Torrejón de Ardoz | Spain | Unknown status |
| Hospital Clínico Lozano Blesa de Zaragoza Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.