Recruiting

New Taipei City 888 Digital Medical AI Platform for Prevention and Care of the Three Highs and Cardio-Renal-Vascular Diseases

ClinicalTrials.gov IDNCT07588256

PhaseNA

Enrollment4162

SponsorNew Taipei City Medical Association

AgeNo minimum reported

SexALL

I'm interested View official listing

Conditions studied

Microalbuminuria, Microalbuminuria /Creatinine Ratios ACR, Cardiovascular Disease Risk Factor, Cardiovascular Disease Prevention, Digital Medicine, Hypertension, Hyperglycaemia (Diabetic), Hyperlipidemia

About this study

Non-communicable diseases (NCDs), or chronic diseases, are a major public health burden globally and in Taiwan, and control of the "three highs" (hypertension, dyslipidemia, and hyperglycemia) is a national priority. Nearly half of the 10 leading causes of death in Taiwan are directly or indirectly related to atherosclerotic cardiovascular disease (ASCVD), for which hypertension, dyslipidemia, and abnormal blood glucose are the major risk factors. National health insurance data indicate that over 70% of middle-aged and older adults have at least one of these chronic conditions. Early stages are often asymptomatic, and inadequate control may lead to complications of cardiovascular disease, stroke, renal vascular disease, and retinopathy, causing irreversible organ damage and death. For blood pressure, large clinical trials such as SPRINT and STEP have shown that targeting systolic blood pressure below 130 mmHg significantly reduces ASCVD events. For LDL cholesterol, "the lower, the better" applies, with guideline-recommended LDL-C targets determined by baseline ASCVD risk, with levels below 55 mg/dL for very high-risk patients. For diabetes, treatment goals generally include fasting plasma glucose below 130 mg/dL and glycated hemoglobin (HbA1c) below 7%. Although antihypertensive therapy has been proven effective in preventing cardiovascular disease and chronic kidney disease attributable to hypertension, fewer than one-third of patients receiving antihypertensive medications achieve current guideline-recommended blood pressure targets. No randomized clinical trial to date has used home blood pressure as the primary therapeutic reference. Moreover, long-term evidence is lacking regarding the organ-protective effects of strategies targeting morning hypertension and of bedtime dosing regimens. Although the TIME study is currently the largest and longest-followed trial addressing dosing time, its bedtime-dosing arm was not specifically targeted to patients with morning hypertension. Therefore, we propose a clinical trial to investigate management strategies for morning hypertension. Aligned with the 2022 Taiwan Hypertension Guidelines, we will employ the "722 protocol" for home blood pressure monitoring and enroll patients with morning home blood pressure ≥130/80 mmHg to compare selective nocturnal administration of antihypertensive agents versus exclusive morning dosing, assessing differences in morning home blood pressure control rates, end-organ damage…

Interventions

Behavioral: Interactive digital modules — Whether the Mobile Digital Health Platform augmented with interactive digital modules improves control rates of the Three Highs (Hypertension, Hyperglycemia, Hyperlipidemia), target organ damages and cardiovascular outcomes
Behavioral: Antihypertensive Medication Management — Therapeutic effects of selective nocturnal versus universal morning antihypertensive dosing on morning home blood pressure control and target organ damages

Primary outcomes

Mean home blood pressure <130/80 mmHg. (24 months from baseline)
LDL-C <100 mg/dL (and <70 mg/dL for patients with diabetes or ASCVD). (24 months from baseline)
HbA1c <6.5% or a reduction of at least 1% from baseline if baseline HbA1c >8% or at least 2% if baseline HbA1c >10%. (24 months from base line)
≥30% reduction in urine albumin to creatinine ratio (UACR). (24 months from baseline)
Improvement in target organ damage (changes in left ventricular mass by AI ECG and in retinal vascular lesions). (24 months from baseline)
• Morning home systolic and diastolic blood pressure at 6 months. (6 months)
• Change in UACR from baseline to 6 months, as a marker of renal target organ protection. (6 months)

Eligibility information

Inclusion Criteria: I.T-888-DIGICARE： Eligible participants must meet the definition of hypertension and at least one of the following chronic (non-hypertensive) conditions: 1. Hypertension * With or without treatment, and meeting one of the following: * Office blood pressure: two consecutive measurements \>130/80 mmHg * Home blood pressure: weekly average (morning/evening) \>130/80 mmHg, or more than half of the weekly measurements exceeding this threshold 2. Hyperlipidemia * With or without treatment, and * LDL-C \>100 mg/dL (or \>70 mg/dL in patients with diabetes or established ASCVD) 3. Diabetes Mellitus * With or without treatment, and * HbA1c \>6.5% 4. Chronic Kidney Disease (CKD) * Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m², and * Urine albumin-to-creatinine ratio (UACR) \>30 mg/g 5. Atherosclerotic Cardiovascular Disease (ASCVD): * Including coronary artery disease, cerebrovascular disease, peripheral arterial disease, or aortic pathology II. DREAM-G: 1. Hypertension * With or without treatment, and meeting one of the following: * Office blood pressure: two consecutive measurements \>130/80 mmHg * Home blood pressure: weekly average (morning/evening) \>130/80 mmHg, or more than half of weekly measurements exceeding this threshold 2. Hyperlipidemia * With or without treatment, and * LDL-C \>100 mg/dL (or \>70 mg/dL in patients with diabetes or established ASCVD) 3. Diabetes Mellitus * With or without treatment, and * HbA1c \>6.5% 4. Chronic Kidney Disease (CKD) * Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m², and * Measurable urinary microalbumin-to-creatinine ratio 5. Atherosclerotic Cardiovascular Disease (ASCVD): • Including coronary artery disease, cerebrovascular disease, peripheral arterial disease, or aortic pathology Participants must meet at least one of the above chronic disease conditions and: 6. Untreated Hypertension: * Morning home blood pressure (HBP) \>130/80 mmHg: weekly average (≥4 days) \>130/80 mmHg, * Or more than half of morning HBP measurements (≥4 days per week) \>130/80 mmHg 7. Treated Hypertension: * Morning home blood pressure \>130/80 mmHg: weekly average (≥4 days) \>130/80 mmHg, * Or more than half of morning HBP measurements (≥4 days per week) \>130/80 mmHg * Average home blood pressure ≤130/80 mmHg (used to determine treatment strategy) Exclusion Criteria: I. T-888-DIGICARE 1. Symptomatic heart failure (New York Heart Association functional class II-IV) 2. End-stage renal disease requiring long-term dialysis 3. Pregnant women or those planning pregnancy II. DREAM-G: 1. Life expectancy \<1 year 2. End-stage renal disease (ESRD) requiring regular renal replacement therapy, including dialysis, kidney transplantation, or palliative care 3. Severe liver cirrhosis 4. Malignancy under active treatment

Study locations

United safety medical group(USMG), New Taipei City, Taiwan

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.