Health TrialsbyHealthPanel

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

ConditionsHypertension,EssentialHypertension, Uncontrolled
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIstituto Auxologico Italiano

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Usual care

    Other intervention

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

  • POST-strategy

    Other intervention

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

Treatment groups

480 Participants
are divided into 2 treatment groups
Group A: Group 1 - Usual careActive comparator 1 intervention
Group B: Group 2 - POST-strategyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ambulatory Systolic Blood Pressure

Change in ambulatory 24h systolic blood pressure

Time frame
12 months

Secondary outcomes

1

Ambulatory Diastolic Blood Pressure

Change in ambulatory 24h diastolic blood pressure

Time frame
12 months
2

Difference between Office Blood Pressure and Home Blood Pressure

Differences between office blood pressure and home blood pressure (both systolic and diastolic)

Time frame
12 months
3

Left ventricular mass index

Change in left ventricular mass index by ecocradiographic evaluation

Time frame
12 months
4

Left ventricular hypertrophy

Change in ECG indices of left ventricular hypertrophy

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Auxologico Italiano

Lead sponsor

Source ClinicalTrials.gov
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