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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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, cardiopul
• Другое Post-examination follow-up management
  Post-examination report interpretation service and telephone follow-up for patients with abnormal findings.

Первичные конечные точки

• Height [Срок оценки: Baseline, Month 12, Month 24]
• Weight [Срок оценки: Baseline, Month 12, Month 24]
• Systolic Blood Pressure [Срок оценки: Baseline, Month 12, Month 24]
• Diastolic Blood Pressure [Срок оценки: Baseline, Month 12, Month 24]
• Heart Rate on 12-Lead Electrocardiogram [Срок оценки: Baseline, Month 12, Month 24]
• PR Interval on 12-Lead Electrocardiogram [Срок оценки: Baseline, Month 12, Month 24]
• QRS Duration on 12-Lead Electrocardiogram [Срок оценки: Baseline, Month 12, Month 24]
• QTc Interval on 12-Lead Electrocardiogram [Срок оценки: Baseline, Month 12, Month 24]
• Left Ventricular Ejection Fraction (LVEF) [Срок оценки: Baseline, Month 12, Month 24]
• Left Ventricular End-Diastolic Diameter (LVEDD) [Срок оценки: Baseline, Month 12, Month 24]

Вторичные конечные точки (12)

• White Blood Cell Count [Срок оценки: Baseline, Month 12, Month 24]
• Red Blood Cell Count [Срок оценки: Baseline, Month 12, Month 24]
• Hemoglobin Concentration [Срок оценки: Baseline, Month 12, Month 24]
• Platelet Count [Срок оценки: Baseline, Month 12, Month 24]
• Urine Red Blood Cell Coun [Срок оценки: Baseline, Month 12, Month 24]
• Urine White Blood Cell Count [Срок оценки: Baseline, Month 12, Month 24]
• Urine Bacterial Count [Срок оценки: Baseline, Month 12, Month 24]
• Concentration of Serum Creatinine [Срок оценки: Baseline, Month 12, Month 24]
• Concentration of Fasting Insulin [Срок оценки: Baseline, Month 12, Month 24]
• Concentration of Serum C-Peptide [Срок оценки: Baseline, Month 12, Month 24]
• Concentration of 25-Hydroxyvitamin D [25(OH)D] [Срок оценки: Baseline, Month 12, Month 24]
• Concentration of Interleukin-6 (IL-6) [Срок оценки: Baseline, Month 12, Month 24]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07452029 · BRWEP2024W014090209 · MR-11-25-027504

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗