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

NCT03206814 | Recruiting

• 1 other identifier: 09A721
• Study Type: interventional
• Target: 480
• Locations: 2 countries
• Sites: 8

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.

Conditions

Hypertension,Essential; Hypertension, Uncontrolled

Keywords

Hypertension; Ambulatory Systolic Blood Pressure; Home Blood Pressure; ESH-CARE APP

Outcome Measures

Primary Outcomes (1)

• Ambulatory Systolic Blood Pressure

  Change in ambulatory 24h systolic blood pressure

  12 months

Secondary Outcomes (9)

• Ambulatory Diastolic Blood Pressure

  12 months

• Difference between Office Blood Pressure and Home Blood Pressure

  12 months

• Left ventricular mass index

  12 months

• Left ventricular hypertrophy

  12 months

• Urinary albumin to creatinine ratio

  12 months

Study Arms (2)

Group 1 - Usual care

ACTIVE COMPARATOR

Standard strategy for management of hypertension, based on three-monthly visits at the referral centre.

Other: Usual care

Group 2 - POST-strategy

EXPERIMENTAL

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

Interventions

Usual care OTHER

Antihypertensive therapy is adjusted every 3 months on the basis of office blood pressure values.

Group 1 - Usual care

POST-strategy OTHER

Antihypertensive therapy is adjusted every 15 days on the basis of home blood pressure values.

Group 2 - POST-strategy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (8)

Private Hospital " Dr Raúl Matera"

Bahía Blanca, B8000, Argentina

RECRUITING

Argerich Hospital

Buenos Aires, C155 AHD, Argentina

RECRUITING

General San Martin Hospital of La Plata

La Plata, 1900, Argentina

RECRUITING

Spanish Hospital of Mendoza

Mendoza, M5501, Argentina

RECRUITING

British Sanatorium of Rosario

Rosario, S2000, Argentina

RECRUITING

Shanghai Institute of Hypertension

Shanghai, Huangpu, China

RECRUITING

Jiangsu Province Official Hospital

Jiangse, 210024, China

ACTIVE NOT RECRUITING

Ruijin Hospital North

Shanghai, 200025, China

RECRUITING

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gianfranco Parati, MD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianfranco Parati, MD

CONTACT

+390261911; gianfranco.parati@unimib.it

Paulina Wijnmaalen, MD

CONTACT

+390261911; charge-app@auxologico.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Centralized reading of ECG, echocardiography and ABPM, blinded for treatment group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: May 11, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AR (5); CN (3)