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

NCT07452029 | Not Yet Recruiting DMC

• 2 other identifiers: BRWEP2024W014090209MR-11-25-027504
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cardiovascular-Kidney-Metabolic Syndrome

Keywords

Comprehensive Health Management Platform; Mobile Health; Early identification; Cardiovascular-Kidney-Metabolic Syndrome

Outcome Measures

Primary Outcomes (31)

• 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 Outcomes (16)

• White Blood Cell Count

  Baseline, Month 12, Month 24

• Red Blood Cell Count

  Baseline, Month 12, Month 24

• Hemoglobin Concentration

  Baseline, Month 12, Month 24

• Platelet Count

  Baseline, Month 12, Month 24

• Urine Red Blood Cell Coun

  Baseline, Month 12, Month 24

Other Outcomes (2)

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

  Baseline, Month 12, Month 24

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

  Baseline, Month 12, Month 24

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Enrolled into a comprehensive health-management platform for cardiorenal metabolic syndrome and received integrated management for 2 years.

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.

Other: Post-examination follow-up management

Interventions

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.

Experimental Arm

Post-examination follow-up management OTHER

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

Control Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: March 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2025-12