Improving Hypertension Control in CHina and ARGEntina With a Mobile APP-based Telecare System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 15
- 主要终点
- Ambulatory Systolic Blood Pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Centralized reading of ECG, echocardiography and ABPM, blinded for treatment group assignment
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Ambulatory Systolic Blood Pressure
时间窗: 12 months
Change in ambulatory 24h systolic blood pressure
次要结局
- Ambulatory Diastolic Blood Pressure(12 months)
- Left ventricular mass index(12 months)
- Difference between Office Blood Pressure and Home Blood Pressure(12 months)
- Left ventricular hypertrophy(12 months)
- Urinary albumin to creatinine ratio(12 months)
- Estimated glomerular filtration rate(12 months)
- Normalization rate of blood pressure(12 months)
- ABPM variables(12 months)
- Prescribed antihypertensive drugs(12 months)