UMIN-CTR Clinical Trial

Public title

Urinary Protein and Albumin Screening and Cardiorenal Care in Hospitalized Cardiovascular Patients

Acronym

CKM-ACTION Study

Scientific Title

A Single-Center Prospective and Retrospective Observational Study Evaluating Urinary Abnormalities and Subsequent Cardiorenal Actions Following Proteinuria and Albuminuria Screening in Hospitalized Cardiovascular Patients

Scientific Title:Acronym

CKM-ACTION Study

Region

Japan

Condition

Cardiovascular diseases

Classification by specialty

Cardiology	Endocrinology and Metabolism	Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To determine the prevalence of urinary abnormalities detected by urinary protein-to-creatinine ratio (UPCR) and urinary albumin-to-creatinine ratio (UACR) among hospitalized cardiovascular patients and to evaluate subsequent cardiorenal actions following the detection of urinary abnormalities. We will also assess diagnosed kidney diseases, longitudinal changes in kidney function, and cardiorenal outcomes.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary outcome is the proportion of patients receiving at least one cardiorenal action addressing a prespecified unmet care need among patients with newly detected urinary abnormalities requiring clinical attention who have at least one such need when the urine test results become clinically available.

Unmet care needs are clinically indicated measures not yet implemented at that time, including confirmation of persistent urinary abnormalities and determination of a nephrology management plan based on repeat testing, diagnostic workup, initiation or adjustment of RAS inhibitors or ARNI, SGLT2 inhibitors, GLP-1 receptor agonists, or mineralocorticoid receptor antagonists including finerenone, and optimization of blood pressure or diabetes management.

Cardiorenal actions comprise these measures undertaken by nephrologists, diabetologists or cardiologists with consideration of cardiovascular-kidney-metabolic (CKM) syndrome. Measures that are not indicated, are precluded by contraindications, intolerance, kidney function, blood pressure, serum potassium or other medical reasons, or are declined by the patient are not classified as unmet care needs.

Key secondary outcomes

1. UPCR/UACR testing rates, urinary abnormality prevalence, and new detection rates in patients with eGFR >=60 mL/min/1.73 m2 and no known kidney disease.
2. Cardiorenal action rates at 30, 90 and 180 days after detection: repeat testing, workup, nephrology assessment and initiation/adjustment of cardiorenal protective drugs.
3. Repeat UPCR/UACR/urine sediment testing rates, changes and persistence of abnormalities at 90 +/-30 days after results become available.
4. Kidney biopsy rate for suspected chronic glomerulonephritis.
5. Frequency and types of nephrologist-diagnosed kidney diseases.
6. eGFR trajectory, sustained >=40% eGFR decline, kidney replacement therapy, all-cause/cardiovascular death, HF hospitalization and major cardiovascular events through 3 years after enrollment.
7. Disease/procedure-specific analyses:
I. Transcatheter treatment of aortic stenosis or mitral/tricuspid regurgitation: pre/post-treatment UPCR/UACR changes in relation to subsequent kidney function and clinical outcomes.
II. HF: admission and stable predischarge UPCR/UACR in relation to SV, TR severity, TAPSE, RV S', TRPG, TAPSE/PASP, IVC diameter and estimated RAP; paired changes at 3-4 months where available.
III. Lower-limb EVT: pretreatment urine findings in relation to wound healing within 1 year in patients with wounds, and major amputation, acute limb ischemia, target-limb revascularization and maintenance dialysis through 3 years. Exploratory associations of SGLT2 inhibitor use with limb outcomes, accounting for urine findings and ischemia severity.
IV. AF ablation: preprocedural urine findings in relation to LA volume/function, clinically assessed LA low-voltage areas and atrial tachyarrhythmia recurrence after a prespecified blanking period through year 1; urine/kidney function changes in relation to sinus rhythm maintenance through year 1 where available; exploratory associations with major bleeding/thromboembolism through year 3.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

100

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients aged 18 years or older.
Patients admitted to the cardiovascular department during the study period who meet at least one of the following criteria:- Undergoing coronary angiography (CAG) or percutaneous coronary intervention (PCI)
- Hospitalization for heart failure
- Undergoing transcatheter aortic valve implantation (TAVI)
- Undergoing transcatheter mitral valve intervention
- Undergoing catheter ablation for atrial fibrillation
- Undergoing endovascular treatment (EVT) for peripheral arterial disease

Key exclusion criteria

Patients receiving maintenance dialysis.
Patients from whom a urine sample cannot be obtained because of anuria or other reasons.
Patients who decline participation in the study.
Patients who have already been enrolled in the study.
Patients considered unsuitable for participation by the investigator or treating physician.

Target sample size

5000

Name of lead principal investigator

1st name	Kenji
Middle name
Last name	Kanenawa

Organization

Kokura memorial hospital

Division name

Cardiology

Zip code

8020001

Address

3-2-1 Asano, Kokura kita-ku,Kitakyushu-city,

TEL

0935112000

Email

kanesannsann@yahoo.co.jp

Name of contact person

1st name	Kenji
Middle name
Last name	Kanenawa

Organization

Kokura memorial hospital

Division name

Cardiology

Zip code

8020001

Address

Asano3-2-1, Kokurakita-ku, Kitakyusyu-shi

TEL

0935112000

Homepage URL

Email

kanesannsann@yahoo.co.jp

Institute

Kokura memorial hospital

Institute

Department

Personal name

Kenji Kanenawa

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Clinical research center,Kokura Memorial Hospital

Address

3-2-1 Asano, Kokura kita-ku,Kitakyushu-city,

Tel

0935112000

Email

rinsyo@kokurakinen.or.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2026

Year

08

Month

25

Day

Date of IRB

2026

Year

08

Month

25

Day

Anticipated trial start date

2026

Year

10

Month

01

Day

Last follow-up date

2030

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a single-center prospective observational study. During hospitalization, UPCR, UACR, urinary sediment, renal function, and diabetes-related parameters will be assessed. Urine samples will generally be collected on the morning after admission, and in patients hospitalized for heart failure, urinary parameters will also be reassessed before discharge after clinical stabilization. In patients with urinary abnormalities, subsequent clinical actions, including repeat testing, etiological evaluation, nephrology assessment, and initiation or modification of cardiorenal protective therapies such as RAS inhibitors/ARNI, SGLT2 inhibitors, GLP-1 receptor agonists, and mineralocorticoid receptor antagonists, will be followed. Clinical management will remain at the discretion of the treating physician, and no specific therapeutic intervention will be mandated by the study. Clinical actions and repeat test results up to 30, 90, and 180 days after urine testing will be collected from medical records.

Registered date

2026

Year

10

Month

01

Day

Last modified on

2026

Year

10

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072260