Improving Hypertension Control in CHina and ARGEntina With a Mobile APP-based Telecare System
Recruiting · NCT03206814 · Interventional (participants receive a specific treatment) · Lead sponsor: Istituto Auxologico Italiano
View the official record on ClinicalTrials.gov →Interventions studied
POST-strategyUsual care
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
8 locations listed.
- Private Hospital " Dr Raúl Matera" - Bahía Blanca, Argentina
- Argerich Hospital - Buenos Aires, Argentina
- Jiangsu Province Official Hospital - Jiangse, China
- General San Martin Hospital of La Plata - La Plata, Argentina
- Spanish Hospital of Mendoza - Mendoza, Argentina
- British Sanatorium of Rosario - Rosario, Argentina
- Ruijin Hospital North - Shanghai, China
- Shanghai Institute of Hypertension - Shanghai, Huangpu, China