NCT03206814 Improving Hypertension Control in CHina and ARGEntina With a Mobile APP-based Telecare System
| NCT ID | NCT03206814 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Auxologico Italiano |
| Condition | Hypertension,Essential |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2021-05-11 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 480 participants in total. It began in 2021-05-11 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Gianfranco Parati, MD
PRINCIPAL INVESTIGATOR
Istituto Auxologico Italiano
Frequently Asked Questions
Who can join the NCT03206814 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hypertension,Essential. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03206814 currently recruiting?
Yes, NCT03206814 is actively recruiting participants. Contact the research team at gianfranco.parati@unimib.it for enrollment information.
Where is the NCT03206814 trial being conducted?
This trial is being conducted at Bahía Blanca, Argentina, Buenos Aires, Argentina, La Plata, Argentina, Mendoza, Argentina and 4 additional locations.
Who is sponsoring the NCT03206814 clinical trial?
NCT03206814 is sponsored by Istituto Auxologico Italiano. The principal investigator is Gianfranco Parati, MD at Istituto Auxologico Italiano. The trial plans to enroll 480 participants.