Mobile app-based telecare system for hypertension management in China and Argentina

Improving Hypertension Control in CHina and ARGEntina With a Mobile APP-based Telecare System

This study is testing a new mobile app to help people with high blood pressure in China and Argentina manage their condition better alongside regular doctor visits.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 480 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Istituto Auxologico Italiano (other)
• Locations: 8 sites (Bahía Blanca and 7 other locations)
• Trial ID: NCT03206814 on ClinicalTrials.gov

What this trial studies

The CHARGE-APP project aims to evaluate an innovative hypertension management strategy that combines standard care visits with the ESH CARE app, compared to traditional care alone. This one-year, randomized, open-label study will enroll patients with uncontrolled hypertension and monitor their blood pressure and related health outcomes over time. Participants will be randomly assigned to either the new management strategy, which includes remote monitoring of home blood pressure readings, or to usual care with regular clinic visits. The study will assess changes in various blood pressure metrics and cardiovascular health indicators throughout the follow-up period.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-80 with uncontrolled hypertension who have access to a compatible smartphone.

Not a fit: Patients with severe uncontrolled hypertension or significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve hypertension control and patient outcomes through enhanced monitoring and management.

How similar studies have performed: Other studies have shown promise with mobile health interventions for hypertension management, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Male and female subjects;
* Age 18-80 years;
* Either the patient or another person close to him/her should possess a smartphone compatible with the ESH CARE app and be capable of using it;
* Uncontrolled (untreated or treated) hypertension, defined as office BP ≥140/90 mmHg, and Ambulatory 24h ABP ≥130/80 mmHg

Exclusion Criteria:

* eGFR \<45 mL/min/1.73 m2 (CKD-EPI creatinine equation 2009);
* Severe uncontrolled hypertension (i.e. BP ≥200/120 mmHg despite treatment);
* Known secondary hypertension;
* Orthostatic hypotension (SBP fall \> 20 mmHg on standing);
* Unstable clinical conditions or severe disease with short life expectation;
* Known atrial fibrillation;
* Hepatic disease as determined by either AST or ALT values \> 2 times the upper limit of normal;
* History of gastrointestinal surgery or disorders which could interfere with drug absorption
* History of malignancy including leukaemia and lymphoma (but not basal cell skin cancer) within the last 5 years;
* History of clinically significant autoimmune disorders such as systemic lupus erythematosus;
* History of drug or alcohol abuse within the last 5 years;
* History of non-compliance to medical regimens and/or patients who are considered potentially unreliable;
* Dementia (clinical diagnosis);
* Inability or unwillingness to give free informed consent;
* Inability to use even simple communication technologies;
* Pregnancy or planned pregnancy during study period

Where this trial is running

Bahía Blanca and 7 other locations

• Private Hospital " Dr Raúl Matera" — Bahía Blanca, Argentina (RECRUITING)
• Argerich Hospital — Buenos Aires, Argentina (RECRUITING)
• General San Martin Hospital of La Plata — La Plata, Argentina (RECRUITING)
• Spanish Hospital of Mendoza — Mendoza, Argentina (RECRUITING)
• British Sanatorium of Rosario — Rosario, Argentina (RECRUITING)
• Shanghai Institute of Hypertension — Shanghai, Huangpu, China (RECRUITING)
• Jiangsu Province Official Hospital — Jiangse, China (ACTIVE_NOT_RECRUITING)
• Ruijin Hospital North — Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Gianfranco Parati, MD — Istituto Auxologico Italiano
• Study coordinator: Gianfranco Parati, MD

Conditions: Hypertension,Essential, Hypertension, Uncontrolled, Hypertension, Ambulatory Systolic Blood Pressure, Home Blood Pressure, ESH-CARE APP