Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03206814 |
| Other study ID # |
09A721 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 11, 2021 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
August 2023 |
| Source |
Istituto Auxologico Italiano |
| Contact |
Gianfranco Parati, MD |
| Phone |
+390261911 |
| Email |
gianfranco.parati[@]unimib.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 intermediate end points at one year, and
changes in a number of blood pressure-related variables throughout the study.
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.
