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

RecruitingNAAges 18 Years - 80 YearsAllIstituto Auxologico Italiano
NCT03206814 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The CHARGE-APP project will investigate whether an innovative management strategy of hypertension based on the combination of usual care visits and ESH CARE App compared to standard care, is associated with differences in outcome, including control rate of office, home and ambulatory BP, cardiovascular and renal intermediate end points at one year, and changes in a number of blood pressure-related variables throughout the study.

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📋 Eligibility rules (as published)
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
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What it tests

  • Usual care
  • POST-strategy
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Where

8 sites
Private Hospital " Dr Raúl Matera"
Bahía Blanca, Argentina
Argerich Hospital
Buenos Aires, Argentina
General San Martin Hospital of La Plata
La Plata, Argentina
Spanish Hospital of Mendoza
Mendoza, Argentina
British Sanatorium of Rosario
Rosario, Argentina
Shanghai Institute of Hypertension
Shanghai, China
Jiangsu Province Official Hospital
Jiangse, China
Ruijin Hospital North
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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