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

Sponsor

Istituto Auxologico Italiano (Other)

Overall Status

Recruiting

CT.gov ID

NCT03206814

Collaborator

(none)

480

Enrollment

Locations

Arms

18.7

Anticipated Duration (Months)

240

Patients Per Site

12.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension,Essential Hypertension, Uncontrolled	Other: Usual care Other: POST-strategy	N/A

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:

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;
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 Design

Study Type:

Interventional

Anticipated Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Centralized reading of ECG, echocardiography and ABPM, blinded for treatment group assignment

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 11, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Ambulatory Systolic Blood Pressure [12 months]
Change in ambulatory 24h systolic blood pressure

Secondary Outcome Measures

Ambulatory Diastolic Blood Pressure [12 months]
Change in ambulatory 24h diastolic blood pressure
Difference between Office Blood Pressure and Home Blood Pressure [12 months]
Differences between office blood pressure and home blood pressure (both systolic and diastolic)
Left ventricular mass index [12 months]
Change in left ventricular mass index by ecocradiographic evaluation
Left ventricular hypertrophy [12 months]
Change in ECG indices of left ventricular hypertrophy
Urinary albumin to creatinine ratio [12 months]
Change in urinary albumin to creatinine ratio
Estimated glomerular filtration rate [12 months]
Change in estimated glomerular filtration rate
Normalization rate of blood pressure [12 months]
Normalization rate of BP by all the measuring devices: office BP, HOME BP and ABPM
ABPM variables [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)
Prescribed antihypertensive drugs [12 months]
Number of prescribed antihypertensive drugs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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