NCT06143995

Brief Summary

The goal of this observational study is to learn about in a total of approximately 2000 patients with cardiovascular disease recruited from about 25 participating sites in China with eGFR\<60 ml/min/1.73 m2 and/or UACR\>30 mg/g at least twice 3 months apart within the previous 12 months who had been hospitalized in the cardiology department within the previous 12 months. The main questions it aims to answer are:

  • To estimate the diagnosis rate of CKD in patients with cardiovascular disease and laboratory evidence of CKD
  • To describe the CKD awareness and treatment pattern in patients with cardiovascular disease and laboratory evidence of CKD.
  • To describe the socio-demographic and clinical characteristics of CKD in patients with cardiovascular disease and laboratory evidence of CKD Participants will be invited to undergo a baseline visit, and the demographics, lifestyle factors, clinical characteristics, and laboratory tests will be collected.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

November 22, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

August 20, 2023

Last Update Submit

November 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • CKD diagnosis rates

    CKD diagnosis rates in overall enrolled patients and subgroups (stratified by isolated estimated glomerular filtration rate (eGFR) measurement, isolated urinary albumin-to-creatinine ratio ( UACR) measurement, and both measurements) will be assessed in 12 month.

    1 day

Secondary Outcomes (3)

  • Clinical characteristics

    1 day

  • CKD diagnosis/treatment rate

    1 day

  • The number, types, treatment rates of medicine

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

a total of approximately 2000 patients with cardiovascular disease recruited from about 25 participating sites in China

You may qualify if:

  • Female and/or male aged ≥18 years
  • Admitted to the cardiology department with diagnosed cardiovascular disease within the previous 12 months
  • Participants with eGFR\<60 ml/min/1.73 m2 and/or UACR\>30 mg/g at least twice 3 months apart within the previous 12 months

You may not qualify if:

  • Participants with known eGFR\<20 ml/min/1.73 m2 or undergoing dialysis or kidney transplantation
  • Pregnant or lactating women
  • Exposure to contrast medium or other reason leading to potential acute kidney injury since the baseline examination of eGFR/UACR
  • Patients who were participating in or had participated in any other clinical trial within the previous 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, ChronicCardiovascular DiseasesDisease

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2023

First Posted

November 22, 2023

Study Start

July 1, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

November 22, 2023

Record last verified: 2023-07

Locations