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NCT Number: NCT07452029

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

1.Construction of a Comprehensive CKM Health-Management Platform

  • 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.
  • Data integration & governance: Health data from electronic health records, laboratory reports and wearables will be unified. Privacy, security and regulatory compliance will be ensured.
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive Health Management Platform

Behavioral

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.

Post-examination follow-up management

Other

Post-examination report interpretation service and telephone follow-up for patients with abnormal findings.

Primary outcomes

  1. Height

    Time frame: Baseline, Month 12, Month 24

    Body height measured in centimeters using a height and weight measuring instrument. Reported as mean value at each assessment time point.

  2. Weight

    Time frame: Baseline, Month 12, Month 24

    Body weight measured in kilograms using a height and weight measuring instrument. Reported as mean value at each assessment time point.

  3. Systolic Blood Pressure

    Time frame: Baseline, Month 12, Month 24

    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.

  4. Diastolic Blood Pressure

    Time frame: Baseline, Month 12, Month 24

    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.

  5. Heart Rate on 12-Lead Electrocardiogram

    Time frame: Baseline, Month 12, Month 24

    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.

  6. PR Interval on 12-Lead Electrocardiogram

    Time frame: Baseline, Month 12, Month 24

    PR interval measured in milliseconds (ms) from 12-lead electrocardiogram. Reported as mean value at each assessment time point.

  7. QRS Duration on 12-Lead Electrocardiogram

    Time frame: Baseline, Month 12, Month 24

    QRS duration measured in milliseconds (ms) from 12-lead electrocardiogram. Reported as mean value at each assessment time point.

  8. QTc Interval on 12-Lead Electrocardiogram

    Time frame: Baseline, Month 12, Month 24

    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.

  9. Left Ventricular Ejection Fraction (LVEF)

    Time frame: Baseline, Month 12, Month 24

    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.

  10. Left Ventricular End-Diastolic Diameter (LVEDD)

    Time frame: Baseline, Month 12, Month 24

    Left ventricular end-diastolic diameter measured in millimeters (mm) using M-mode echocardiography. Reported as mean value at each assessment time point.

  11. Concentration of Lactate Dehydrogenase (LDH)

    Time frame: Baseline, Month 12, Month 24

    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.

  12. Concentration of Alpha-Hydroxybutyrate Dehydrogenase (α-HBDH)

    Time frame: Baseline, Month 12, Month 24

    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.

  13. Concentration of Creatine Kinase (CK)

    Time frame: Baseline, Month 12, Month 24

    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.

  14. Concentration of Creatine Kinase-MB (CK-MB)

    Time frame: Baseline, Month 12, Month 24

    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.

  15. Urine Occult Blood

    Time frame: Baseline, Month 12, Month 24

    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.

  16. Urine Protein

    Time frame: Baseline, Month 12, Month 24

    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.

  17. Concentration of Total Bilirubin

    Time frame: Baseline, Month 12, Month 24

    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.

  18. Concentration of Total Protein

    Time frame: Baseline, Month 12, Month 24

    Serum total protein concentration measured in grams per liter (g/L) using biuret method. Reported as mean value at each assessment time point.

  19. Concentration of Albumin

    Time frame: Baseline, Month 12, Month 24

    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.

  20. Concentration of Direct Bilirubin

    Time frame: Baseline, Month 12, Month 24

    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.

  21. Activity of Aspartate Aminotransferase (AST)

    Time frame: Baseline, Month 12, Month 24

    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.

  22. Activity of Alanine Aminotransferase (ALT)

    Time frame: Baseline, Month 12, Month 24

    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.

  23. Concentration of Globulin

    Time frame: Baseline, Month 12, Month 24

    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.

  24. Concentration of Uric Acid

    Time frame: Baseline, Month 12, Month 24

    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.

  25. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Baseline, Month 12, Month 24

    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.

  26. Concentration of Total Cholesterol

    Time frame: Baseline, Month 12, Month 24

    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.

  27. Concentration of Triglycerides

    Time frame: Baseline, Month 12, Month 24

    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.

  28. Concentration of Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Baseline, Month 12, Month 24

    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.

  29. Concentration of High-Density Lipoprotein Cholesterol (HDL-C)

    Time frame: Baseline, Month 12, Month 24

    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.

  30. Concentration of Fasting Plasma Glucose

    Time frame: Baseline, Month 12, Month 24

    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.

  31. Concentration of Glycated Hemoglobin (HbA1c)

    Time frame: Baseline, Month 12, Month 24

    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.

Secondary outcomes

  1. White Blood Cell Count

    Time frame: Baseline, Month 12, Month 24

    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.

  2. Red Blood Cell Count

    Time frame: Baseline, Month 12, Month 24

    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.

  3. Hemoglobin Concentration

    Time frame: Baseline, Month 12, Month 24

    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.

  4. Platelet Count

    Time frame: Baseline, Month 12, Month 24

    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.

  5. Urine Red Blood Cell Coun

    Time frame: Baseline, Month 12, Month 24

    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.

  6. Urine White Blood Cell Count

    Time frame: Baseline, Month 12, Month 24

    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.

  7. Urine Bacterial Count

    Time frame: Baseline, Month 12, Month 24

    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.

  8. Concentration of Serum Creatinine

    Time frame: Baseline, Month 12, Month 24

    Serum creatinine concentration measured in micromoles per liter (μmol/L) using enzymatic method. Reported as mean value at each assessment time point.

  9. Concentration of Fasting Insulin

    Time frame: Baseline, Month 12, Month 24

    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.

  10. Concentration of Serum C-Peptide

    Time frame: Baseline, Month 12, Month 24

    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.

  11. Concentration of 25-Hydroxyvitamin D [25(OH)D]

    Time frame: Baseline, Month 12, Month 24

    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.

  12. Concentration of Interleukin-6 (IL-6)

    Time frame: Baseline, Month 12, Month 24

    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.

  13. Concentration of Interleukin-10 (IL-10)

    Time frame: Baseline, Month 12, Month 24

    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.

  14. Concentration of Interleukin-1β (IL-1β)

    Time frame: Baseline, Month 12, Month 24

    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.

  15. Concentration of Tumor Necrosis Factor-alpha (TNF-α)

    Time frame: Baseline, Month 12, Month 24

    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.

  16. Concentration of High-Sensitivity C-Reactive Protein (hs-CRP)

    Time frame: Baseline, Month 12, Month 24

    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.

Other outcomes

  1. Score on International Physical Activity Questionnaire-Short Form (IPAQ-SF)

    Time frame: Baseline, Month 12, Month 24

    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.

  2. Score on 36-Item Short Form Health Survey (SF-36)

    Time frame: Baseline, Month 12, Month 24

    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.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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