Construction of a Comprehensive Health Management Platform for Patients With Cardiovascular-Kidney-Metabolic Syndrome

Cardiovascular-Kidney-Metabolic (CKM) syndrome underscores the pathophysiologic interplay among metabolic risk factors, chronic kidney disease (CKD) and the cardiovascular system. This crosstalk precipitates multi-organ dysfunction, increases adverse cardiovascular events, and imposes heavy familial and socioeconomic burdens. Building a health-management platform within research wards is therefore urgent. Such a platform is the pivotal venue for assessment, monitoring, intervention and follow-up in continuous care.

Leveraging the existing health-management system of the Health Screening Center at Peking University Third Hospital, the investigators will develop a comprehensive CKM platform that integrates systemic inflammatory biomarkers, cardiovascular early-warning algorithms, and personalized diet-and-exercise prescriptions. The system will provide cyclic management encompassing evaluation, guidance, monitoring, feedback and longitudinal follow-up.

A randomized controlled trial with two-year prospective follow-up will enroll patients at CKM stages 0-2 to evaluate clinical improvement, quality of life, dietary behavior and physical activity after platform enrollment. The project will enable early identification of high-risk individuals, deliver precision management, maximize data utility, and offer a novel research-ward model that addresses mobile-health pain points and closes the CKM care loop.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular-Kidney-Metabolic Syndrome
• Intervention / Treatment: Behavioral: Comprehensive Health Management Platform; Other: Post-examination follow-up management

Detailed Description

1.Construction of a Comprehensive CKM Health-Management Platform

1. Needs analysis & user research: Drawing on parallel work on CKM inflammatory biomarkers, cardiovascular early-warning algorithms and personalised exercise prescriptions, the investigators will use literature review, focus groups and expert panels to elicit needs of CKM patients and clinicians. The platform will provide screening, assessment, intervention and longitudinal follow-up-e.g. individual exercise/diet plans, tele-consultation and data analytics.
2. Data integration & governance: Health data from electronic health records, laboratory reports and wearables will be unified. Privacy, security and regulatory compliance will be ensured.
3. Remote monitoring & online consultation: Real-time monitoring and tele-consultation will improve access. Issues such as network latency, data security and service quality will be addressed.

2. Deployment and feasibility evaluation CKM stage 0-2 patients meeting diagnostic criteria will receive two-year comprehensive management via the platform. Clinical metrics and quality-of-life indices will be used to evaluate feasibility, early identification of high-risk individuals, improvement of composite CKM endpoints and patient-centred outcomes.

3. Innovation highlights This project will deliver the first Chinese integrated health-information platform dedicated to CKM syndrome. It unites systemic inflammatory biomarkers, cardiovascular (early-warning) algorithms and individualised diet/exercise modules into one (closed-loop) system that continuously monitors, profiles, analyses, risk-stratifies, manages and follows each patient. Multi-dimensional data (physiology, lifestyle, genetics) feed an individualised management cycle of "monitor-profile-analyse-risk-score-intervene-follow-up", offering a novel methodologic and theoretical framework for early risk detection and precision intervention in CKM.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• CKM stage 0-2 as defined by the American Heart Association CKM diagnostic guidelines
• Age 18-75 years
• Able to use a smartphone and wearable activity tracker
• Willing to sign informed consent and attend scheduled follow-up visits

Exclusion Criteria:

• CKM stage 3-4
• Acute or critically ill conditions requiring hospitalization
• Malignant tumors or any active cancer under treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; Enrolled into a comprehensive health-management platform for cardiorenal metabolic syndrome and received integrated management for 2 years.	Behavioral: Comprehensive Health Management Platform; The health-management programme comprises: Screening: collection of demographic data, medical and personal history, physical examination (blood pressure, heart rate, etc.), laboratory tests (inflammatory markers, lipids, glucose, renal and liver function), exercise habits, nutritional status, body-composition analysis, and physical-fitness tests (reaction time, grip strength, vertical jump, one-leg stance with eyes closed, back strength, sit-and-reach, 1-min sit-ups, 1-min push-ups, cardiopulmonary exercise test).Assessment: CKM risk stratification based on the above. ③ Intervention: individualised exercise, dietary and pharmacological prescriptions.Follow-up: ongoing monitoring of clinical indices, exercise, diet and medication adherence by a physician-health-manager team.
Active Comparator: Control Arm; The control group receives routine post-examination follow-up and health management provided by the health check-up center.	Other: Post-examination follow-up management; Post-examination report interpretation service and telephone follow-up for patients with abnormal findings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Body height measured in centimeters using a height and weight measuring instrument. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Weight	Body weight measured in kilograms using a height and weight measuring instrument. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Systolic Blood Pressure	Systolic blood pressure measured in millimeters of mercury (mmHg) using an automated sphygmomanometer after 5 minutes of rest. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Diastolic Blood Pressure	Diastolic blood pressure measured in millimeters of mercury (mmHg) using an automated sphygmomanometer after 5 minutes of rest. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Heart Rate on 12-Lead Electrocardiogram	Heart rate measured in beats per minute (bpm) from 12-lead electrocardiogram recorded after 10 minutes of rest in supine position. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
PR Interval on 12-Lead Electrocardiogram	PR interval measured in milliseconds (ms) from 12-lead electrocardiogram. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
QRS Duration on 12-Lead Electrocardiogram	QRS duration measured in milliseconds (ms) from 12-lead electrocardiogram. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
QTc Interval on 12-Lead Electrocardiogram	Corrected QT interval (QTc) measured in milliseconds (ms) using Bazett's formula from 12-lead electrocardiogram. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Left Ventricular Ejection Fraction (LVEF)	Left ventricular ejection fraction measured as percentage (%) using two-dimensional echocardiography with Simpson's biplane method. Higher values indicate better cardiac function. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Left Ventricular End-Diastolic Diameter (LVEDD)	Left ventricular end-diastolic diameter measured in millimeters (mm) using M-mode echocardiography. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Lactate Dehydrogenase (LDH)	Serum lactate dehydrogenase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Alpha-Hydroxybutyrate Dehydrogenase (α-HBDH)	Serum alpha-hydroxybutyrate dehydrogenase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Creatine Kinase (CK)	Serum creatine kinase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Creatine Kinase-MB (CK-MB)	Serum creatine kinase-MB isoenzyme activity measured in units per liter (U/L) using immunoinhibition assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.	Baseline, Month 12, Month 24
Urine Occult Blood	Presence of occult blood in urine detected using dipstick method. Reported as number and percentage of participants with positive result (1+ or greater) at each assessment time point.	Baseline, Month 12, Month 24
Urine Protein	Presence of protein in urine detected using dipstick method. Reported as number and percentage of participants with positive result (1+ or greater) at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Total Bilirubin	Serum total bilirubin concentration measured in micromoles per liter (μmol/L) using diazo method. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Total Protein	Serum total protein concentration measured in grams per liter (g/L) using biuret method. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Albumin	Serum albumin concentration measured in grams per liter (g/L) using bromocresol green method. Reported as mean value and number of participants with values below lower limit of normal (LLN) at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Direct Bilirubin	Serum direct (conjugated) bilirubin concentration measured in micromoles per liter (μmol/L) using diazo method with caffeine accelerator. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Activity of Aspartate Aminotransferase (AST)	Serum aspartate aminotransferase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.	Baseline, Month 12, Month 24
Activity of Alanine Aminotransferase (ALT)	Serum alanine aminotransferase activity measured in units per liter (U/L) using kinetic enzymatic assay. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Globulin	Serum globulin concentration calculated as the difference between total protein and albumin concentrations, measured in grams per liter (g/L). Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Uric Acid	Serum uric acid concentration measured in micromoles per liter (μmol/L) using uricase method. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.	Baseline, Month 12, Month 24
Estimated Glomerular Filtration Rate (eGFR)	Estimated glomerular filtration rate calculated in milliliters per minute per 1.73 square meters (mL/min/1.73m²) using CKD-EPI equation based on serum creatinine and cystatin C. Higher values indicate better kidney function. Reported as mean value and number of participants with eGFR <60 mL/min/1.73m² at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Total Cholesterol	Serum total cholesterol concentration measured in millimoles per liter (mmol/L) using enzymatic colorimetric assay after overnight fasting. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Triglycerides	Serum triglyceride concentration measured in millimoles per liter (mmol/L) using enzymatic glycerol phosphate oxidase method after overnight fasting. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Low-Density Lipoprotein Cholesterol (LDL-C)	Serum LDL-C concentration measured in millimoles per liter (mmol/L) using direct enzymatic assay or calculated using Friedewald formula after overnight fasting. Lower values indicate better cardiovascular risk profile. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Concentration of High-Density Lipoprotein Cholesterol (HDL-C)	Serum HDL-C concentration measured in millimoles per liter (mmol/L) using direct enzymatic assay after overnight fasting. Higher values indicate better cardiovascular risk profile. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Fasting Plasma Glucose	Fasting plasma glucose concentration measured in millimoles per liter (mmol/L) using hexokinase method after at least 8 hours of fasting. Reported as mean value and number of participants with values ≥7.0 mmol/L at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Glycated Hemoglobin (HbA1c)	HbA1c level measured as percentage (%) using high-performance liquid chromatography (HPLC) method standardized to National Glycohemoglobin Standardization Program (NGSP). Lower values indicate better glycemic control. Reported as mean value and number of participants with HbA1c ≥6.5% at each assessment time point.	Baseline, Month 12, Month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
White Blood Cell Count	White blood cell count measured in 10^9 cells per liter (10^9/L) using automated hematology analyzer. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Red Blood Cell Count	Red blood cell count measured in 10^12 cells per liter (10^12/L) using automated hematology analyzer. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Hemoglobin Concentration	Hemoglobin concentration measured in grams per liter (g/L) using cyanmethemoglobin method. Reported as mean value and number of participants with values below lower limit of normal (LLN) at each assessment time point.	Baseline, Month 12, Month 24
Platelet Count	Platelet count measured in 10^9 cells per liter (10^9/L) using automated hematology analyzer. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Urine Red Blood Cell Coun	Red blood cell count in urine measured in cells per high-power field (cells/HPF) using microscopic examination of centrifuged urine sediment. Reported as mean value and number of participants with values above 3 cells/HPF at each assessment time point.	Baseline, Month 12, Month 24
Urine White Blood Cell Count	White blood cell count in urine measured in cells per high-power field (cells/HPF) using microscopic examination of centrifuged urine sediment. Reported as mean value and number of participants with values above 5 cells/HPF at each assessment time point.	Baseline, Month 12, Month 24
Urine Bacterial Count	Bacterial count in urine measured in colony-forming units per milliliter (CFU/mL) using quantitative urine culture. Reported as number and percentage of participants with bacterial count ≥10^5 CFU/mL at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Serum Creatinine	Serum creatinine concentration measured in micromoles per liter (μmol/L) using enzymatic method. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Fasting Insulin	Serum fasting insulin concentration measured in picomoles per liter (pmol/L) or microunits per milliliter (μIU/mL) using chemiluminescent immunoassay after at least 8 hours of fasting. Reported as mean value and calculated Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) index at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Serum C-Peptide	Serum C-peptide concentration measured in nanomoles per liter (nmol/L) or nanograms per milliliter (ng/mL) using chemiluminescent immunoassay after at least 8 hours of fasting. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Concentration of 25-Hydroxyvitamin D [25(OH)D]	Serum 25-hydroxyvitamin D concentration measured in nanomoles per liter (nmol/L) or nanograms per milliliter (ng/mL) using chemiluminescent immunoassay (CLIA) or liquid chromatography-tandem mass spectrometry (LC-MS/MS). 25(OH)D is the major circulating form of vitamin D and reflects vitamin D status. Higher values indicate better vitamin D sufficiency. Reported as mean value and number of participants with 25(OH)D <50 nmol/L (20 ng/mL) indicating deficiency, 50-75 nmol/L (20-30 ng/mL) indicating insufficiency, and ≥75 nmol/L (30 ng/mL) indicating sufficiency at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Interleukin-6 (IL-6)	Serum interleukin-6 concentration measured in picograms per milliliter (pg/mL) using high-sensitivity enzyme-linked immunosorbent assay (ELISA) or chemiluminescent immunoassay. IL-6 is a pro-inflammatory cytokine. Lower values indicate lower systemic inflammation. Reported as mean value and number of participants with values above upper limit of normal (ULN) at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Interleukin-10 (IL-10)	Serum interleukin-10 concentration measured in picograms per milliliter (pg/mL) using enzyme-linked immunosorbent assay (ELISA) or chemiluminescent immunoassay. IL-10 is an anti-inflammatory cytokine. Higher values may indicate compensatory anti-inflammatory response. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Interleukin-1β (IL-1β)	Serum interleukin-1β concentration measured in picograms per milliliter (pg/mL) using high-sensitivity enzyme-linked immunosorbent assay (ELISA). IL-1β is a key pro-inflammatory cytokine. Lower values indicate lower systemic inflammation. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Concentration of Tumor Necrosis Factor-alpha (TNF-α)	Serum tumor necrosis factor-alpha concentration measured in picograms per milliliter (pg/mL) using high-sensitivity enzyme-linked immunosorbent assay (ELISA) or chemiluminescent immunoassay. TNF-α is a major pro-inflammatory cytokine. Lower values indicate lower systemic inflammation. Reported as mean value at each assessment time point.	Baseline, Month 12, Month 24
Concentration of High-Sensitivity C-Reactive Protein (hs-CRP)	Serum high-sensitivity C-reactive protein concentration measured in milligrams per liter (mg/L) using immunoturbidimetric assay or nephelometry. hs-CRP is an acute-phase reactant and marker of systemic inflammation. Lower values indicate lower cardiovascular risk and systemic inflammation. Reported as mean value and number of participants with hs-CRP <1 mg/L (low risk), 1-3 mg/L (moderate risk), and >3 mg/L (high risk) for cardiovascular disease at each assessment time point.	Baseline, Month 12, Month 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on International Physical Activity Questionnaire-Short Form (IPAQ-SF)	Physical activity level assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), a 7-item self-administered questionnaire measuring the frequency and duration of vigorous-intensity activity, moderate-intensity activity, and walking during the past 7 days. Total physical activity is calculated as metabolic equivalent of task (MET)-minutes per week, categorized as low (<600 MET-min/week), moderate (600-3000 MET-min/week), or high (>3000 MET-min/week) activity level. Higher MET-minutes indicate higher physical activity level. Reported as mean total MET-minutes per week and number of participants in each activity category at each assessment time point.	Baseline, Month 12, Month 24
Score on 36-Item Short Form Health Survey (SF-36)	Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36), a 36-item self-administered questionnaire measuring eight health domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). Each domain score ranges from 0 to 100, with higher scores indicating better health status. Two summary component scores are calculated: Physical Component Summary (PCS) and Mental Component Summary (MCS). Reported as mean scores for each domain and summary components at each assessment time point.	Baseline, Month 12, Month 24

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: March 1, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Mobile Health; Early identification; Cardiovascular-Kidney-Metabolic Syndrome; Comprehensive Health Management Platform
• Other Study ID Numbers: BRWEP2024W014090209; MR-11-25-027504 (Registry Identifier: National Universal Health Assurance Information Platform - Medical Research Registration and Filing Information System)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No