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Cardiovascular Diseases (CVD)CKM-LCBPNCT07547098

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

An observational study of Cardiovascular Diseases (CVD) and Chronic Kidney Disease, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
8,000 participants
Where
1 siteChina
Study dates
1 Mar 2026to 28 Feb 2031
How long will I take part?
5 Years
Phase
Observational
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hailin Zhang contact

824224843@qq.com

China1 site, 1 recruiting
  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350011

    Hailin Zhang, 008659187981637, 824224843@qq.com

    Recruiting

Other trials in China

About this study

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.

Read the detailed description

This study is a single-center CKM patient registry with retrospective data entry and prospective lifecycle follow-up. A patient-centered master index will be established primarily on the basis of hospitalization identifiers to integrate multi-source hospital data, including discharge records, diagnoses, laboratory testing, medications, electrocardiography, echocardiography, baPWV/ABI, carotid ultrasound, abdominal ultrasound, bone density, coronary CTA and post-processing metrics, and clinical outcome events. A structured longitudinal database will be created to support standardized phenotyping, event adjudication, and repeat-assessment tracking. The primary objective is to build a dynamic registry platform for CKM-related inpatients and to support long-term follow-up, outcome surveillance, risk stratification, and real-world evidence generation. The study is planned for 5 years, from March 1, 2026 to February 28, 2031, with annual active follow-up and monthly passive data updates. Major outcomes include a time-to-first cardiorenal composite endpoint, all-cause mortality, 3-point major adverse cardiovascular events, heart failure hospitalization or cardiovascular death, and additional pre-specified cardiovascular, renal, metabolic, oncologic, cognitive, and imaging progression outcomes.

Keywords
CKM syndrome, Cardiovascular-Kidney-Metabolic, Patient registry, Real-world data
Medical subject headings
Cardiovascular Diseases, Renal Insufficiency, Chronic, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07547098
Study groupRoleWhat they receive
CKM Registry CohortAdults 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 5 years from enrollment

Secondary outcomes (10)
  1. All-cause mortality

    Time to death from any cause during follow-up.

    Measured: Up to 5 years from enrollment

  2. 3-point major adverse cardiovascular events (3-point MACE)

    Time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal ischemic stroke.

    Measured: Up to 5 years from enrollment

  3. First hospitalization for heart failure or cardiovascular death

    Time to first hospitalization for heart failure or cardiovascular death during follow-up.

    Measured: Up to 5 years from enrollment.

  4. Nonfatal Myocardial Infarction

    First occurrence of nonfatal myocardial infarction during follow-up.

    Measured: Up to 5 years from enrollment

  5. Nonfatal Ischemic Stroke

    First occurrence of nonfatal ischemic stroke during follow-up.

    Measured: Up to 5 years from enrollment

  6. Incident Atrial Fibrillation

    New-onset atrial fibrillation among participants without a history of atrial fibrillation at baseline, confirmed by 12-lead electrocardiography, Holter monitoring, or inpatient/outpatient clinical diagnosis during follow-up.

    Measured: Up to 5 years from enrollment

  7. Coronary Revascularization

    First occurrence of coronary revascularization, including percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), during follow-up.

    Measured: Up to 5 years from enrollment

  8. Aortic Disease Intervention

    First occurrence of endovascular or surgical intervention for aortic dissection, aortic aneurysm, penetrating aortic ulcer, or other aortic diseases during follow-up.

    Measured: Up to 5 years from enrollment

  9. Peripheral Vascular Events

    First occurrence of peripheral vascular events, including acute limb ischemia, peripheral arterial revascularization, or major amputation due to vascular causes.

    Measured: From enrollment until the date of first documented peripheral vascular event, death, loss to follow-up, or end of study, whichever came first, assessed up to 5 years.

  10. Incident Diabetes Mellitus

    New-onset diabetes mellitus among participants without diabetes at baseline, defined as a new clinical diagnosis of diabetes, initiation of glucose-lowering therapy, or laboratory evidence meeting diagnostic criteria during follow-up.

    Measured: Up to 5 years from enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study start1 Mar 2026
  3. Primary completion28 Feb 2031 (estimated)
  4. Study completion28 Feb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
8,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07547098
Sponsor's protocol ID
MRCTA,ECFAH of FMU[2026]046
Acronym
CKM-LCBP
Status last verified
Mar 2026
First submitted
13 Apr 2026
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: De-identified individual participant data may be considered for sharing subject to institutional approval, data security requirements, ethics approval where applicable, and the minimum necessary principle. A formal data-sharing policy has not yet been finalized at the time of registration.

Publications

  • 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.

    PubMed 40671108
  • 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.

    PubMed 41272273
  • 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.

    PubMed 39255681
  • 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.

    PubMed 39706244
  • 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.

    PubMed 40073760
  • 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.

    PubMed 40287685
  • 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.

    PubMed 40042920
  • 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.

    PubMed 40563333
  • 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.

    PubMed 39556396
  • 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.

    PubMed 41421989
  • 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.

    PubMed 39486671
  • 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.

    PubMed 39160192
  • 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.

    PubMed 39705194
  • 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.

    PubMed 40104608
  • 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.

    PubMed 39932805

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases (CVD) and Chronic Kidney Disease, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.

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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Contact Dajun Chai (008659187981637, dajunchai-fy@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First occurrence of a cardiorenal composite endpoint (time frame: Up to 5 years from enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07547098, which also lists 16 linked publications.

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 23 Apr 2026.

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