NCT06242483Completed
The ELFIE-HYPERTENSION
The ELFIE-HYPERTENSION Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
The ELFIE-HYPERTENSION randomized clinical trial is an academic-led, collaborative, pragmatic, randomized, open-label, parallel arm, multicenter, trial evaluating whether a digital health intervention based on the Elfie solution compared with usual care will reduce systolic blood pressure in individuals with hypertension.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 930 (actual)
- First submitted
- 29 Jan 2024
- Start date
- 14 Jun 2024
- Primary completion date
- 8 Apr 2026
- Lead sponsor
- Hospital Israelita Albert Einstein
- Diseases
- High blood pressure
- NCT number
- NCT06242483
What you commit to
- Study type: Interventional
- Participants enrolled: 930
- From 14 Jun 2024 to the primary completion date, 8 Apr 2026
- 16 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
- Current use of a health app with the aim to improve medication adherence and blood pressure control
- Known use of illicit drugs or alcoholism
Other illness
- Known cognitive decline, dementia, or diagnosis of severe psychiatric conditions (depression, schizophrenia, bipolar disorder)
Other
- Refusal to provide written informed consent
- Illiteracy to read in the local language
- Current participation in a cardiovascular randomized clinical trial
- Life expectancy \< 1 year
Who the study is looking for
- Age ≥ 18 years and ≤ 75 years
- Male and female patients
- Hypertension diagnosis based on the local guidelines criteria
- Uncontrolled blood pressure (systolic blood pressure ≥ 140 mmHg) on the screening visit
- Patients in whom medication adherence needs to be improved according to the healthcare provider clinical judgment
- Use of at least 1 anti-hypertensive medication
- Ownership of an active smartphone with operational system iOS (version 13.0 or later) or Android (version 8.0 or later) with access to the internet on 3G, 4G or 5G
- Ability to use a smartphone app
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clínica do Coração - JMF Coordinator of this site? Confirm its status | Aracaju | Brazil | Unknown status |
| NF. Pacheco Cardiologia Humanizada Coordinator of this site? Confirm its status | Belém | Brazil | Unknown status |
| Hospital Universitário São Francisco na Providência de Deus Coordinator of this site? Confirm its status | Bragança Paulista | Brazil | Unknown status |
| Hosp. Universitário UFG Coordinator of this site? Confirm its status | Goiânia | Brazil | Unknown status |
| Hospital Municipal Aparecida de Goiania Coordinator of this site? Confirm its status | Goiânia | Brazil | Unknown status |
| Centro de Pesquisa Clínica de Guarulhos Coordinator of this site? Confirm its status | Guarulhos | Brazil | Unknown status |
| Rede AME Saúde Coordinator of this site? Confirm its status | Recife | Brazil | Unknown status |
| Hospital Universitário Pedro Ernesto Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| CETRUS - Diagnostica LTDA Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital Israelita Albert Einstein Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Elizabeth Do Espirito Santo Eireli Coordinator of this site? Confirm its status | Votuporanga | Brazil | Unknown status |
| 354 Military Hospital Coordinator of this site? Confirm its status | Hanoi | Vietnam | Unknown status |
| National Geriatric Hospital Coordinator of this site? Confirm its status | Hanoi | Vietnam | Unknown status |
| District 4 Hospital Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
| Gia Dinh hospital Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
| Nguyen Tri Phuong Hospital Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.