Improving Hypertension Control in CHina and ARGEntina With a Mobile APP-based Telecare System
Istituto Auxologico Italiano
480 participants
May 11, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria16
- 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
Interventions
Antihypertensive therapy is adjusted every 3 months on the basis of office blood pressure values.
Antihypertensive therapy is adjusted every 15 days on the basis of home blood pressure values.
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03206814