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RecruitingNCT05397392ODT-CRSUpdated Jun 2, 2022

Research on Optimal Diagnosis and Treatment of Cardiorenal Syndrome

An observational study in Heart Failure, Kidney Diseases and Kidney Injury, sponsored by Nanjing First Hospital, Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-02.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Observational

From the registry’s dates

  • Started Jan 2016; still recruiting 10 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,200
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

Cardiorenal syndrome is a clinical syndrome caused by acute or chronic injury of one of the heart and kidney resulting to acute or chronic dysfunction of the other organ. In recent years, the morbidity of cardiorenal syndrome has increased rapidly in China. Its condition is complex and difficult to treat. Due to the lack of studies specifically targeting the cardiorenal syndrome population, there is no systematic in-depth understanding of the pathogenesis and risk factors of this kind of disease. In clinic, the course of various types of cardiorenal syndrome is complex and difficult to be summarized into a specific type. Therefore, we intend to conduct a clinical systematic observation and research on such patients so as to optimize a more reasonable treatment scheme.

02

Conditions studied

  • Heart Failure
  • Kidney Diseases
  • Kidney Injury
  • Heart Valve Diseases
  • Dialysis; Complications
  • Coronary Heart Disease
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 213 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients from a tertiary hospital

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Otherguideline recommended routine treatment
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

  2. All-cause deaths

    Deaths due to disease progression

    Time frame: 1 year

Secondary outcomes

  1. End-stage renal disease requires maintenance dialysis

    eGFR\<15ml/min, combined with one of the following conditions: 1. Uremia symptoms that cannot be alleviated by limiting protein intake; 2. Hyperkalemia that is difficult to correct; 3. Progressive metabolic acidosis that is difficult to control; 4. Uncontrollable water and sodium retention, combined with congestive heart failure or acute pulmonary edema; 5. Uremic pericarditis; 6. Uremic encephalopathy and progressive neuropathy.

    Time frame: 1 year

  2. Acute kidney injury

    increase in Scr ≥0.3 mg/dL (26.5 μmol/L) within 48 h, or increase in Scr ≥1.5 times baseline in 7 days, or urine volume \<0.5 mL/kg/h for 6 h.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Nanjing, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05397392
Lead sponsor
Nanjing First Hospital, Nanjing Medical University
Responsible party
Sponsor
First posted
May 31, 2022
Start date
Jan 2016
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 2, 2022

Study contacts

Yue Zhou, master of medicine
Contact
56005460@qq.com
+8615380998793
Xiao-xia Chen, master of medicine
Contact
zygyx2022@163.com
+8615380998950

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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