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

Last updated: February 26, 2025
Sponsor: Istituto Auxologico Italiano
Overall Status: Active - Recruiting

Phase

N/A

Condition

High Blood Pressure (Hypertension)

Diabetes And Hypertension

Circulation Disorders

Treatment

Usual care

POST-strategy

Clinical Study ID

NCT03206814
09A721
  • Ages 18-80
  • All Genders

Study 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

Inclusion Criteria:

  • Male and female subjects;

  • Age 18-80 years;

  • Either the patient or another person close to him/her should possess a smartphonecompatible 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

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 limitof normal;

  • History of gastrointestinal surgery or disorders which could interfere with drugabsorption

  • History of malignancy including leukaemia and lymphoma (but not basal cell skincancer) within the last 5 years;

  • History of clinically significant autoimmune disorders such as systemic lupuserythematosus;

  • History of drug or alcohol abuse within the last 5 years;

  • History of non-compliance to medical regimens and/or patients who are consideredpotentially 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

Study Design

Total Participants: 480
Treatment Group(s): 2
Primary Treatment: Usual care
Phase:
Study Start date:
May 11, 2021
Estimated Completion Date:
December 31, 2025

Study Description

CHARGE-APP is a proof-of-concept one-year prospective, randomized, open-label, blinded endpoint study (PROBE) including 2 groups of patients randomized to different treatment strategies:

  1. a new management strategy, named POST (i.e. "Patient Optimal Strategy for Treatment"), consisting in providing the patients with a system to communicate home blood pressure measurements to a referral centre, and the referral centre with an online platform to organize and easily interpret the information sent by patients and to monitor the patients' status;

  2. usual care, consisting in regular visits at the referral centre.

Patients will be enrolled over 3 months and will be randomly allocated to one of the study groups. Follow-up phase will last 12 months after randomization and will focus on changes in ambulatory systolic BP (primary endpoint), in diastolic ambulatory BP, in office SBP and DBP, in Home SBP and DBP, in left ventricular mass index (LVMI) and urinary albumin excretion (UAE), all secondary end-points.

All patients will perform visits at baseline, three, six and twelve months. Physical examination, history of the patient and clinical blood pressure values will be obtained at every visit.

Echocardiogram, ECG, urine samples (UAE, urinary albumin/creatinine and 24-h ambulatory blood pressure monitoring (ABPM) will be performed at baseline, three months, six months and study end.

Blood samples (full blood count, creatinine, Na+, K+, fasting glucose, HbA1c, uric acid, lipids) will be performed at baseline; another blood sample will be collected at twelve months for measurement of serum creatinine (and renal function). UAE will be measured at baseline and study end, on morning urine samples.

Patients randomized to POST-strategy will measure Home BP two days a week (two measurements in the morning and two measurements in the evening) and communicate these values with the ESH CARE app; furthermore, before each visit they will measure their Home BP for 7 consecutive days (two measurements in the morning and two measurements in the evening), according to current guidelines on hypertension.

Patients randomized to usual care will also measure Home BP for 7 consecutive days at baseline and at study end, to provide a comparison. Operators (i.e. investigators dedicated to the follow-up of POST-strategy) will check these data organized by the POST system at least every 15 days, and adjust pharmacological therapy, if needed.

In patients randomized to usual care, therapy will be adjusted only at follow-up visits (i.e. at three and six months).

Pharmacological therapy will be increased or decreased according to blood pressure values; investigators may follow a therapy algorithm based on ESH/ESC guidelines, but are free to individualize it.

Connect with a study center

  • Private Hospital " Dr Raúl Matera"

    Bahia Blanca, B8000
    Argentina

    Active - Recruiting

  • Argerich Hospital

    Buenos Aires, C155 AHD
    Argentina

    Active - Recruiting

  • General San Martin Hospital of La Plata

    La Plata, 1900
    Argentina

    Active - Recruiting

  • Spanish Hospital of Mendoza

    Mendoza, M5501
    Argentina

    Active - Recruiting

  • British Sanatorium of Rosario

    Rosario, S2000
    Argentina

    Active - Recruiting

  • Shanghai Institute of Hypertension

    Shanghai, Huangpu
    China

    Active - Recruiting

  • Jiangsu Province Official Hospital

    Jiangse, 210024
    China

    Site Not Available

  • Ruijin Hospital North

    Shanghai, 200025
    China

    Active - Recruiting

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