Improving Hypertension Control in CHina and ARGEntina With a Mobile APP-based Telecare System (CHARGE-APP)
Primary Purpose
Hypertension,Essential, Hypertension, Uncontrolled
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Usual care
POST-strategy
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension,Essential focused on measuring Hypertension, Ambulatory Systolic Blood Pressure, Home Blood Pressure, ESH-CARE APP
Eligibility Criteria
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
Sites / Locations
- Spanish Hospital of Mendoza
- Shanghai Institute of HypertensionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group 1 - Usual care
Group 2 - POST-strategy
Arm Description
Standard strategy for management of hypertension, based on three-monthly visits at the referral centre.
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.
Outcomes
Primary Outcome Measures
Ambulatory Systolic Blood Pressure
Change in ambulatory 24h systolic blood pressure
Secondary Outcome Measures
Ambulatory Diastolic Blood Pressure
Change in ambulatory 24h diastolic blood pressure
Difference between Office Blood Pressure and Home Blood Pressure
Differences between office blood pressure and home blood pressure (both systolic and diastolic)
Left ventricular mass index
Change in left ventricular mass index by ecocradiographic evaluation
Left ventricular hypertrophy
Change in ECG indices of left ventricular hypertrophy
Urinary albumin to creatinine ratio
Change in urinary albumin to creatinine ratio
Estimated glomerular filtration rate
Change in estimated glomerular filtration rate
Normalization rate of blood pressure
Normalization rate of BP by all the measuring devices: office BP, HOME BP and ABPM
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)
Prescribed antihypertensive drugs
Number of prescribed antihypertensive drugs
Full Information
NCT ID
NCT03206814
First Posted
June 30, 2017
Last Updated
August 22, 2023
Sponsor
Istituto Auxologico Italiano
1. Study Identification
Unique Protocol Identification Number
NCT03206814
Brief Title
Improving Hypertension Control in CHina and ARGEntina With a Mobile APP-based Telecare System
Acronym
CHARGE-APP
Official Title
Improving Hypertension Control in CHina and ARGEntina With a Mobile APP-based Telecare System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Auxologico Italiano
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,Essential, Hypertension, Uncontrolled
Keywords
Hypertension, Ambulatory Systolic Blood Pressure, Home Blood Pressure, ESH-CARE APP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Centralized reading of ECG, echocardiography and ABPM, blinded for treatment group assignment
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 - Usual care
Arm Type
Active Comparator
Arm Description
Standard strategy for management of hypertension, based on three-monthly visits at the referral centre.
Arm Title
Group 2 - POST-strategy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Antihypertensive therapy is adjusted every 3 months on the basis of office blood pressure values.
Intervention Type
Other
Intervention Name(s)
POST-strategy
Intervention Description
Antihypertensive therapy is adjusted every 15 days on the basis of home blood pressure values.
Primary Outcome Measure Information:
Title
Ambulatory Systolic Blood Pressure
Description
Change in ambulatory 24h systolic blood pressure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Ambulatory Diastolic Blood Pressure
Description
Change in ambulatory 24h diastolic blood pressure
Time Frame
12 months
Title
Difference between Office Blood Pressure and Home Blood Pressure
Description
Differences between office blood pressure and home blood pressure (both systolic and diastolic)
Time Frame
12 months
Title
Left ventricular mass index
Description
Change in left ventricular mass index by ecocradiographic evaluation
Time Frame
12 months
Title
Left ventricular hypertrophy
Description
Change in ECG indices of left ventricular hypertrophy
Time Frame
12 months
Title
Urinary albumin to creatinine ratio
Description
Change in urinary albumin to creatinine ratio
Time Frame
12 months
Title
Estimated glomerular filtration rate
Description
Change in estimated glomerular filtration rate
Time Frame
12 months
Title
Normalization rate of blood pressure
Description
Normalization rate of BP by all the measuring devices: office BP, HOME BP and ABPM
Time Frame
12 months
Title
ABPM variables
Description
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)
Time Frame
12 months
Title
Prescribed antihypertensive drugs
Description
Number of prescribed antihypertensive drugs
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gianfranco Parati, MD
Phone
+390261911
Ext
2890
Email
gianfranco.parati@unimib.it
First Name & Middle Initial & Last Name or Official Title & Degree
Paulina Wijnmaalen, MD
Phone
+390261911
Ext
2968
Email
charge-app@auxologico.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianfranco Parati, MD
Organizational Affiliation
Istituto Auxologico Italiano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spanish Hospital of Mendoza
City
Mendoza
ZIP/Postal Code
M5501
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Renna, MD
Email
nicolasfede@gmail.com
Facility Name
Shanghai Institute of Hypertension
City
Shanghai
State/Province
Huangpu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiguang Wang, Prof
Email
jiguangw@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Hypertension Control in CHina and ARGEntina With a Mobile APP-based Telecare System
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