Study on Construction of Whole Lifecycle Cohort, Big Data Management and Clinical Prognosis of Cardio-Renal-Metabolic (CKM) Syndrome

NCT07547098 | Recruiting DMC

• 1 other identifier: MRCTA,ECFAH of FMU[2026]046
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center observational registry study aiming to establish a structured clinical and multimodal imaging database for cardiovascular-kidney-metabolic (CKM) populations and to support lifecycle follow-up and outcome management. Adult patients aged 18-80 years with cardiovascular, kidney, and/or metabolic diseases or key data for CKM phenotyping will be enrolled at the First Affiliated Hospital of Fujian Medical University. The study integrates retrospective data entry and prospective follow-up, including clinical records, laboratory tests, medications, electrocardiography, echocardiography, vascular function assessment, carotid and abdominal ultrasound, bone density, coronary CTA and post-processing data. The primary outcome is the first occurrence of a cardiorenal composite endpoint. Participants will be followed for up to 5 years through active annual follow-up and passive monthly data updates to support risk stratification, real-world evidence generation, and CKM management pathway optimization.

Conditions

Cardiovascular Diseases (CVD); Chronic Kidney Disease; Metabolic Diseases; Cardiovascular-kidney-metabolic Syndrome

Keywords

CKM syndrome; Cardiovascular-Kidney-Metabolic; Patient registry; Real-world data

Outcome Measures

Primary Outcomes (1)

• First occurrence of a cardiorenal composite endpoint

  Time to first occurrence of cardiovascular death or kidney disease progression, defined as sustained decline in eGFR of at least 40% from baseline, sustained eGFR below 15 mL/min/1.73 m², initiation of maintenance dialysis, kidney transplantation, or renal death.

  Up to 5 years from enrollment

Secondary Outcomes (10)

• All-cause mortality

  Up to 5 years from enrollment

• 3-point major adverse cardiovascular events (3-point MACE)

  Up to 5 years from enrollment

• First hospitalization for heart failure or cardiovascular death

  Up to 5 years from enrollment.

• Nonfatal Myocardial Infarction

  Up to 5 years from enrollment

• Nonfatal Ischemic Stroke

  Up to 5 years from enrollment

Other Outcomes (8)

• Incident Malignant Tumor

  Up to 5 years from enrollment

• Incident Dementia Based on Clinical Diagnosis Records

  From enrollment until the date of first documented incident dementia, death, loss to follow-up, or end of study, whichever came first, assessed up to 5 years.

• Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score

  Baseline and annual follow-up assessments through longitudinal follow-up, assessed up to 5 years.

Study Arms (1)

CKM Registry Cohort

Adults aged 18 to 80 years receiving inpatient care at the First Affiliated Hospital of Fujian Medical University with cardiovascular disease, kidney disease, metabolic disease, or key examination and laboratory data supporting CKM phenotyping, enrolled for structured data collection and longitudinal follow-up.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital-based adult CKM-related inpatients at the First Affiliated Hospital of Fujian Medical University with available clinical and multimodal examination data for longitudinal registry follow-up.

You may qualify if:

• Age 18 years or older.
• Inpatient record available at the First Affiliated Hospital of Fujian Medical University with retrievable identifiers for data linkage.
• Cardiovascular disease, kidney disease, metabolic disease, or key examination/laboratory information supporting CKM phenotyping.
• Willingness to participate and provision of written informed consent.
• Ability to complete baseline assessment and follow-up.
• Full civil capacity and ability to understand study information.

You may not qualify if:

• Refusal to provide written informed consent.
• Severe psychiatric disease or cognitive impairment precluding participation.
• End-stage disease with expected survival less than 1 year.
• Long-term absence more than 6 months preventing reliable follow-up.
• Participation in another clinical study that may interfere with endpoint adjudication.
• Missing key fields preventing linkage of examinations, imaging, and outcomes.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350011, China

RECRUITING

Related Publications (16)

• Duan L, Yang H, Chen Z, Zhao J, Yang J, Cai D. Dietary antioxidants and mortality in early-stage CKM syndrome: insights from NHANES. Nutr Metab (Lond). 2025 Jul 16;22(1):77. doi: 10.1186/s12986-025-00974-5.

  PMID: 40671108 BACKGROUND

• Chen Q, Zhu Y, Gao J, Ni W, Liu S, Rui F, Bai X, Geng N, Jin R, Sun Y, Chen Y, Fan Z, Wu C, Qi X, Shi J, Li J. Cardiovascular-kidney-metabolic (CKM) syndrome is associated with increased mortality in individuals with metabolic dysfunction-associated steatotic liver disease (MASLD). Commun Med (Lond). 2025 Nov 21;5(1):492. doi: 10.1038/s43856-025-01195-w.

  PMID: 41272273 BACKGROUND

• Li N, Li Y, Cui L, Shu R, Song H, Wang J, Chen S, Liu B, Shi H, Gao H, Huang T, Gao X, Geng T, Wu S. Association between different stages of cardiovascular-kidney-metabolic syndrome and the risk of all-cause mortality. Atherosclerosis. 2024 Oct;397:118585. doi: 10.1016/j.atherosclerosis.2024.118585. Epub 2024 Aug 30.

  PMID: 39255681 BACKGROUND

• Rumrill SM, Shlipak MG. The New Cardiovascular-Kidney-Metabolic (CKM) Syndrome: An Opportunity for CKD Detection and Treatment in Primary Care. Am J Kidney Dis. 2025 Apr;85(4):399-402. doi: 10.1053/j.ajkd.2024.09.016. Epub 2024 Dec 18. No abstract available.

  PMID: 39706244 BACKGROUND

• Chen Y, Wu S, Liu H, Zhong Z, Bucci T, Wang Y, Zhao M, Liu Y, Yang Z, Gue Y, McDowell G, Huang B, Lip GYH. Role of oxidative balance score in staging and mortality risk of cardiovascular-kidney-metabolic syndrome: Insights from traditional and machine learning approaches. Redox Biol. 2025 Apr;81:103588. doi: 10.1016/j.redox.2025.103588. Epub 2025 Mar 7.

  PMID: 40073760 BACKGROUND

• Zheng Q, Cao Z, Teng J, Lu Q, Huang P, Zhou J. Association between atherogenic index of plasma with all-cause and cardiovascular mortality in individuals with Cardiovascular-Kidney-Metabolic syndrome. Cardiovasc Diabetol. 2025 Apr 26;24(1):183. doi: 10.1186/s12933-025-02742-4.

  PMID: 40287685 BACKGROUND

• Xie Z, Yu C, Cui Q, Zhao X, Zhuang J, Chen S, Guan H, Li J. Global Burden of the Key Components of Cardiovascular-Kidney-Metabolic Syndrome. J Am Soc Nephrol. 2025 Mar 5;36(8):1572-1584. doi: 10.1681/ASN.0000000658.

  PMID: 40042920 BACKGROUND

• Guerrero-Mauvecin J, Villar-Gomez N, Mino-Izquierdo L, Povo-Retana A, Ramos AM, Ruiz-Hurtado G, Sanchez-Nino MD, Ortiz A, Sanz AB. Antioxidant Effects of SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic (CKM) Syndrome. Antioxidants (Basel). 2025 Jun 9;14(6):701. doi: 10.3390/antiox14060701.

  PMID: 40563333 BACKGROUND

• Zhu R, Wang R, He J, Wang L, Chen H, Niu X, Sun Y, Guan Y, Gong Y, Zhang L, An P, Li K, Ren F, Xu W, Guo J. Prevalence of Cardiovascular-Kidney-Metabolic Syndrome Stages by Social Determinants of Health. JAMA Netw Open. 2024 Nov 4;7(11):e2445309. doi: 10.1001/jamanetworkopen.2024.45309.

  PMID: 39556396 BACKGROUND

• Papadakis Z. Exercise in CKM syndrome progression: a stage-specific approach to cardiovascular, metabolic, and renal health. Cardiovasc Diabetol. 2025 Dec 20;24(1):462. doi: 10.1186/s12933-025-03029-4.

  PMID: 41421989 BACKGROUND

• Kittelson KS, Junior AG, Fillmore N, da Silva Gomes R. Cardiovascular-kidney-metabolic syndrome - An integrative review. Prog Cardiovasc Dis. 2024 Nov-Dec;87:26-36. doi: 10.1016/j.pcad.2024.10.012. Epub 2024 Oct 30.

  PMID: 39486671 BACKGROUND

• Gao C, Gao S, Zhao R, Shen P, Zhu X, Yang Y, Duan C, Wang Y, Ni H, Zhou L, Xiang Y, Li M, Xu Z, Wang Y, Yang H, Zhao C. Association between systemic immune-inflammation index and cardiovascular-kidney-metabolic syndrome. Sci Rep. 2024 Aug 19;14(1):19151. doi: 10.1038/s41598-024-69819-0.

  PMID: 39160192 BACKGROUND

• Ferdinand KC. An overview of cardiovascular-kidney-metabolic syndrome. Am J Manag Care. 2024 Dec;30(10 Suppl):S181-S188. doi: 10.37765/ajmc.2024.89670.

  PMID: 39705194 BACKGROUND

• Javaid A, Hariri E, Ozkan B, Lang K, Khan SS, Rangaswami J, Stone NJ, Blumenthal RS, Ndumele CE. Cardiovascular-Kidney-Metabolic (CKM) Syndrome: A Case-Based Narrative Review. Am J Med Open. 2025 Jan 30;13:100089. doi: 10.1016/j.ajmo.2025.100089. eCollection 2025 Jun.

  PMID: 40104608 BACKGROUND

• Claudel SE, Schmidt IM, Waikar SS, Verma A. Cumulative Incidence of Mortality Associated with Cardiovascular-Kidney-Metabolic (CKM) Syndrome. J Am Soc Nephrol. 2025 Feb 11;36(7):1343-1351. doi: 10.1681/ASN.0000000637.

  PMID: 39932805 BACKGROUND

• Sebastian SA, Padda I, Johal G. Cardiovascular-Kidney-Metabolic (CKM) syndrome: A state-of-the-art review. Curr Probl Cardiol. 2024 Feb;49(2):102344. doi: 10.1016/j.cpcardiol.2023.102344. Epub 2023 Dec 14.

  PMID: 38103820 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Renal Insufficiency, Chronic; Metabolic Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases

Study Officials

• Dajun Chai

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dajun Chai

CONTACT

008659187981637; dajunchai-fy@fjmu.edu.cn

Hailin Zhang

CONTACT

824224843@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician, Department of Cardiology

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 23, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 28, 2031
• Study Completion (Estimated): February 28, 2031
• Last Updated: April 23, 2026

Record last verified: 2026-03

Locations

CN (1)