Hypertension,EssentialCHARGE-APPNCT03206814
Improving Hypertension Control in CHina and ARGEntina With a Mobile APP-based Telecare System
A study testing POST-strategy in people with Hypertension,Essential and Hypertension, Uncontrolled, run by Istituto Auxologico Italiano at 8 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension,Essential, Hypertension, Uncontrolled
- What is being tested?
- POST-strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 11 May 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 16Show fewer
- 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
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
Argentina5 sites, 5 recruiting
- Recruiting
Private Hospital " Dr Raúl Matera"
Bahía Blanca, B8000
Ricardo Plunkett, MD, 012rplunkett@gmail.com
- Recruiting
Argerich Hospital
Buenos Aires, C155 AHD
Judith Zilberman, MD, juzilberman@gmail.com
Vanina Szczygiel, chargeapp.argentina@gmail.com
- Recruiting
General San Martin Hospital of La Plata
La Plata, 1900
Walter Espeche, MD, wespeche@gmail.com
- Recruiting
Spanish Hospital of Mendoza
Mendoza, M5501
Nicolas Renna, MD, nicolasfede@gmail.com
- Recruiting
British Sanatorium of Rosario
Rosario, S2000
Daniel Piskorz, MD, daniel.piskorz@hotmail.com
China3 sites, 2 recruiting
- Active, not recruiting
Jiangsu Province Official Hospital
Jiangse, 210024
- Recruiting
Shanghai Institute of Hypertension
Shanghai, Huangpu
Jiguang Wang, Prof, jiguangw@163.com
- Recruiting
Ruijin Hospital North
Shanghai, 200025
Xin Chen, MD, heartmedi@163.com
Zhe Hu, pisces880305@126.com
About this study
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.
Read the 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.
- Conditions
- Hypertension,Essential, Hypertension, Uncontrolled
- Being tested
- Usual care, POST-strategy
- Keywords
- Hypertension, Ambulatory Systolic Blood Pressure, Home Blood Pressure, ESH-CARE APP
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
Antihypertensive therapy is adjusted every 3 months on the basis of office blood pressure values.
POST-strategyOther
Antihypertensive therapy is adjusted every 15 days on the basis of home blood pressure values.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Usual care | Active comparator | Standard strategy for management of hypertension, based on three-monthly visits at the referral centre. Receives: 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. Receives: Other: POST-strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory Systolic Blood Pressure
Change in ambulatory 24h systolic blood pressure
Measured: 12 months
Secondary outcomes (9)
Ambulatory Diastolic Blood Pressure
Change in ambulatory 24h diastolic blood pressure
Measured: 12 months
Difference between Office Blood Pressure and Home Blood Pressure
Differences between office blood pressure and home blood pressure (both systolic and diastolic)
Measured: 12 months
Left ventricular mass index
Change in left ventricular mass index by ecocradiographic evaluation
Measured: 12 months
Left ventricular hypertrophy
Change in ECG indices of left ventricular hypertrophy
Measured: 12 months
Urinary albumin to creatinine ratio
Change in urinary albumin to creatinine ratio
Measured: 12 months
Estimated glomerular filtration rate
Change in estimated glomerular filtration rate
Measured: 12 months
Normalization rate of blood pressure
Normalization rate of BP by all the measuring devices: office BP, HOME BP and ABPM
Measured: 12 months
ABPM variables
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)
Measured: 12 months
Prescribed antihypertensive drugs
Number of prescribed antihypertensive drugs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start11 May 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianfranco Parati, MD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206814
- Sponsor's protocol ID
- 09A721
- Acronym
- CHARGE-APP
- Status last verified
- Feb 2025
- First submitted
- 30 Jun 2017
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Hypertension Control in CHina and ARGEntina With a Mobile APP-based Telecare System
- ClinicalTrials.gov ID
- NCT03206814
- Acronym / sponsor ID
- CHARGE-APP / 09A721
- Conditions
- Hypertension,Essential, Hypertension, Uncontrolled
- Keywords
- Hypertension, Ambulatory Systolic Blood Pressure, Home Blood Pressure, ESH-CARE APP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Usual care | Active comparator | Other: Usual careStandard strategy for management of hypertension, based on three-monthly visits at the referral centre. |
| Group 2 - POST-strategy | Experimental | Other: POST-strategyPatient 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careAntihypertensive therapy is adjusted every 3 months on the basis of office blood pressure values. | Other | Group 1 - Usual care |
| POST-strategyAntihypertensive therapy is adjusted every 15 days on the basis of home blood pressure values. | Other | Group 2 - POST-strategy |
Primary outcome
Ambulatory Systolic Blood Pressure
Time frame: 12 months
Change in ambulatory 24h systolic blood pressure
9 secondary outcomes
Ambulatory Diastolic Blood Pressure
Time frame: 12 months
Difference between Office Blood Pressure and Home Blood Pressure
Time frame: 12 months
Left ventricular mass index
Time frame: 12 months
Left ventricular hypertrophy
Time frame: 12 months
Urinary albumin to creatinine ratio
Time frame: 12 months
Estimated glomerular filtration rate
Time frame: 12 months
Normalization rate of blood pressure
Time frame: 12 months
ABPM variables
Time frame: 12 months
Prescribed antihypertensive drugs
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Hypertension,Essential
Active, not recruitingPhase 1
Safety, Tolerability, PK and PD of ADX-850 in Participants With Hypertension
Hypertension, Hypertension,Essential
Recruiting
Air Pollution and Cardiovascular Disease in Qatar: an Interventional Study to Reduce Blood Pressure
Hypertension, Systolic, Metabolic Syndrome
Recruiting
An Extension Trial of GW 906 in Participants With Essential Hypertension
Hypertension
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy
Essential Hypertension, Type 2 Diabetes Mellitus
RecruitingObservational study
Global Paradise System US Post Approval Study
Hypertension, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gianfranco Parati, MD principal investigator
Istituto Auxologico Italiano
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POST-strategy in people with Hypertension,Essential and Hypertension, Uncontrolled, run by Istituto Auxologico Italiano at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Argentina, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianfranco Parati, MD (+390261911 ext. 2890, gianfranco.parati@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory Systolic Blood Pressure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.