Cardiovascular-Kidney-Metabolic SyndromeNCT07452029
Construction of a Comprehensive Health Management Platform for Patients With Cardiovascular-Kidney-Metabolic Syndrome
A study testing Comprehensive Health Management Platform and Post-examination follow-up management in people with Cardiovascular-Kidney-Metabolic Syndrome, run by Peking University Third Hospital.
Trial summary
Cardiovascular-Kidney-Metabolic (CKM) syndrome underscores the pathophysiologic interplay among metabolic risk factors, chronic kidney disease (CKD) and the cardiovascular system. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiovascular-Kidney-Metabolic Syndrome
- What is being tested?
- Comprehensive Health Management Platform and Post-examination follow-up management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- CKM stage 3-4
- Acute or critically ill conditions requiring hospitalization
- Malignant tumors or any active cancer under treatment
About this study
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.
Read the detailed description
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.
- Conditions
- Cardiovascular-Kidney-Metabolic Syndrome
- Being tested
- Comprehensive Health Management Platform, Post-examination follow-up management
- Keywords
- Comprehensive Health Management Platform, Mobile Health, Early identification, Cardiovascular-Kidney-Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Health Management PlatformBehavioural
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 managementOther
Post-examination report interpretation service and telephone follow-up for patients with abnormal findings.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Enrolled into a comprehensive health-management platform for cardiorenal metabolic syndrome and received integrated management for 2 years. Receives: Behavioral: Comprehensive Health Management Platform |
| Control Arm | Active comparator | The control group receives routine post-examination follow-up and health management provided by the health check-up center. Receives: Other: Post-examination follow-up management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
Body height measured in centimeters using a height and weight measuring instrument. Reported as mean value at each assessment time point.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 12, Month 24
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 12, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular-Kidney-Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452029
- Sponsor's protocol ID
- BRWEP2024W014090209
- Other IDs
- MR-11-25-027504
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Comprehensive Health Management Platform for Patients With Cardiovascular-Kidney-Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT07452029
- Acronym / sponsor ID
- BRWEP2024W014090209
- Conditions
- Cardiovascular-Kidney-Metabolic Syndrome
- Keywords
- Comprehensive Health Management Platform, Mobile Health, Early identification, Cardiovascular-Kidney-Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Behavioral: Comprehensive Health Management PlatformEnrolled into a comprehensive health-management platform for cardiorenal metabolic syndrome and received integrated management for 2 years. |
| Control Arm | Active comparator | Other: Post-examination follow-up managementThe control group receives routine post-examination follow-up and health management provided by the health check-up center. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- CKM stage 3-4
- Acute or critically ill conditions requiring hospitalization
- Malignant tumors or any active cancer under treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Health Management PlatformThe 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. | Behavioural | Experimental Arm |
| Post-examination follow-up managementPost-examination report interpretation service and telephone follow-up for patients with abnormal findings. | Other | Control Arm |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
16 secondary outcomes
White Blood Cell Count
Time frame: Baseline, Month 12, Month 24
Red Blood Cell Count
Time frame: Baseline, Month 12, Month 24
Hemoglobin Concentration
Time frame: Baseline, Month 12, Month 24
Platelet Count
Time frame: Baseline, Month 12, Month 24
Urine Red Blood Cell Coun
Time frame: Baseline, Month 12, Month 24
Urine White Blood Cell Count
Time frame: Baseline, Month 12, Month 24
Urine Bacterial Count
Time frame: Baseline, Month 12, Month 24
Concentration of Serum Creatinine
Time frame: Baseline, Month 12, Month 24
Concentration of Fasting Insulin
Time frame: Baseline, Month 12, Month 24
Concentration of Serum C-Peptide
Time frame: Baseline, Month 12, Month 24
Concentration of 25-Hydroxyvitamin D [25(OH)D]
Time frame: Baseline, Month 12, Month 24
Concentration of Interleukin-6 (IL-6)
Time frame: Baseline, Month 12, Month 24
Concentration of Interleukin-10 (IL-10)
Time frame: Baseline, Month 12, Month 24
Concentration of Interleukin-1β (IL-1β)
Time frame: Baseline, Month 12, Month 24
Concentration of Tumor Necrosis Factor-alpha (TNF-α)
Time frame: Baseline, Month 12, Month 24
Concentration of High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: Baseline, Month 12, Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Health Management Platform and Post-examination follow-up management in people with Cardiovascular-Kidney-Metabolic Syndrome, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height (time frame: Baseline, Month 12, Month 24). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.