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

February 26, 2025 updated by: Istituto Auxologico Italiano
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Bahia Blanca, Argentina, B8000
      • Buenos Aires, Argentina, C155 AHD
      • La Plata, Argentina, 1900
        • Recruiting
        • General San Martin Hospital of La Plata
        • Contact:
      • Mendoza, Argentina, M5501
      • Rosario, Argentina, S2000
  • China
      • Jiangse, China, 210024
        • Active, not recruiting
        • Jiangsu Province Official Hospital
      • Shanghai, China, 200025
    • Huangpu
      • Shanghai, Huangpu, China
        • Recruiting
        • Shanghai Institute of Hypertension
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 - Usual care
Standard strategy for management of hypertension, based on three-monthly visits at the referral centre.
Other: Usual care
Antihypertensive therapy is adjusted every 3 months on the basis of office blood pressure values.
Experimental: Group 2 - POST-strategy
Patient Optimal Strategy for Treatment (POST) for management of hypertension, based on on three-monthly visits at the referral centre + providing the patients with the ESH-CARE APP system to communicate home blood pressure measurements to the referral centre, and the referral centre with an online platform to monitor the patients' status.
Other: POST-strategy
Antihypertensive therapy is adjusted every 15 days on the basis of home blood pressure values.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ambulatory Systolic Blood Pressure
Time Frame: 12 months
Change in ambulatory 24h systolic blood pressure
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ambulatory Diastolic Blood Pressure
Time Frame: 12 months
Change in ambulatory 24h diastolic blood pressure
12 months
Difference between Office Blood Pressure and Home Blood Pressure
Time Frame: 12 months
Differences between office blood pressure and home blood pressure (both systolic and diastolic)
12 months
Left ventricular mass index
Time Frame: 12 months
Change in left ventricular mass index by ecocradiographic evaluation
12 months
Left ventricular hypertrophy
Time Frame: 12 months
Change in ECG indices of left ventricular hypertrophy
12 months
Urinary albumin to creatinine ratio
Time Frame: 12 months
Change in urinary albumin to creatinine ratio
12 months
Estimated glomerular filtration rate
Time Frame: 12 months
Change in estimated glomerular filtration rate
12 months
Normalization rate of blood pressure
Time Frame: 12 months
Normalization rate of BP by all the measuring devices: office BP, HOME BP and ABPM
12 months
ABPM variables
Time Frame: 12 months
Change in a number of variables derived from ABPM (day-time SBP/DBP, Night-time SBP/DBP, nocturnal dipping of SBP/DBP, morning surge of SBP/DBP, BPV (daytime and night-time SBP/SBP SD, CV; 24h SBP/DBP ARV, 24h SBP/DBP wSD, AASI)
12 months
Prescribed antihypertensive drugs
Time Frame: 12 months
Number of prescribed antihypertensive drugs
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Investigators

  • Principal Investigator: Gianfranco Parati, MD, Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 30, 2017

First Submitted That Met QC Criteria

June 30, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09A721

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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