NCT05397392

Brief Summary

To estimate the characteristics, pathogenesis, risk factors and intervention measures for different stages of heart and kidney diseases, and to optimize the curative effects of different treatment schemes

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress88%
Jan 2016Dec 2027

Study Start

First participant enrolled

January 1, 2016

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 2, 2022

Status Verified

April 1, 2022

Enrollment Period

10.9 years

First QC Date

May 26, 2022

Last Update Submit

May 30, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Hospitalization due to worsening of renal or cardiac function

    eGFR continuously decreased by more than 25% within one year; NYHA cardiac function class III or above requires intravenous pharmacological agents; deterioration of cardiac or kidney function requiring dialysis

    1 year

  • All-cause deaths

    Deaths due to disease progression

    1 year

Secondary Outcomes (2)

  • End-stage renal disease requires maintenance dialysis

    1 year

  • Acute kidney injury

    1 year

Study Arms (2)

acute kidney injury

Acute kidney injury caused by heart disease or cardiac dysfunction due to acute renal damage

Other: guideline recommended routine treatment

chornic kidney disease

Chornic kidney injury caused by heart disease or cardiac dysfunction due to chronic kidney disease

Other: guideline recommended routine treatment

Interventions

acute kidney injurychornic kidney disease

Eligibility Criteria

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

Patients from a tertiary hospital

You may qualify if:

  • Patients meet the diagnosis of various types of cardiorenal syndrome according to the classification standards of various types formulated by KDIGO and ADQI expert consensus. Different syndromes were identified and classified into five subtypes. Acute CRS (type 1): acute worsening of heart function (AHF-ACS) leading to kidney injury and/or dysfunction. Chronic cardio-renal syndrome (type 2): chronic abnormalities in heart function (CHF-CHD) leading to kidney injury and/or dysfunction. Acute reno-cardiac syndrome (type 3): acute worsening of kidney function (AKI) leading to heart injury and/or dysfunction. Chronic reno-cardiac syndrome (type 4): chronic kidney disease leading to heart injury, disease, and/or dysfunction. Secondary CRS (type 5): systemic conditions leading to simultaneous injury and/or dysfunction of heart and kidney.

You may not qualify if:

  • Pregnant or breastfeeding women; Female patients with recent birth plans; Patients who cannot follow up on medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Nanjing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Heart FailureKidney DiseasesHeart Valve DiseasesCoronary Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesMyocardial IschemiaVascular Diseases

Central Study Contacts

Yue Zhou, master of medicine

CONTACT

Xiao-xia Chen, master of medicine

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2022

First Posted

May 31, 2022

Study Start

January 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

June 2, 2022

Record last verified: 2022-04

Locations