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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Gianfranco Parati, MD — Istituto Auxologico Italiano
• Study coordinator: Gianfranco Parati, MD
• Email: gianfranco.parati@unimib.it
• Phone: +390261911

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.