N/A
Completed N=97
Multicenter Trial for the Validation of Vitalera Platform
Chronic Patients · Heart Failure
Source: ClinicalTrials.gov NCT05825755 ↗
Enrolled (actual)
97
Serious AEs
18.0%
Results posted
Mar 2025
Primary outcomePrimary: Change in Quality of Life Scale Between Baseline and 3-months Follow-up — -24; -32.5 units on a scale — p=0.252
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quality of Life Scale Between Baseline and 3-months Follow-up |
-24; -32.5 | 0.252 |
| PRIMARY Change in the Proportion of Treatment Adherent Patients Between Baseline and 3-months Follow-up. |
0.056; 0.068 | 1.0 |
| PRIMARY Change in Sel-care Behaviour Scale Between Baseline and 3-months Follow-up |
-4; -4 | 0.791 |
| SECONDARY Mortality From Any Cause |
0; 2 | — |
| SECONDARY Number of Hospital Readmissions |
7; 7 | — |
| SECONDARY Number of Visits to the Emergency Room Due to HF Decompensation |
2; 0 | — |
| SECONDARY Number of Emergency Visits for CV Causes |
3; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Oncology patients with metastasis or with chemotherapy treatment ongoing
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT05825755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.