Research on Optimal Diagnosis and Treatment of Cardiorenal Syndrome

Recruiting

• Conditions: Heart Failure; Coronary Heart Disease; Kidney Injury; Kidney Diseases; Heart Valve Diseases; Dialysis; Complications
• Interventions: Other: guideline recommended routine treatment

• Registration Number: NCT05397392
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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

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.

Study Timeline

• Study Start: 2016-01
• Status Verified: 2022-04
• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-05-26
• Last Update Submitted: 2022-05-30
• Study First Posted: 2022-05-31
• Last Update Posted: 2022-06-02
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
acute kidney injury	guideline recommended routine treatment	Acute kidney injury caused by heart disease or cardiac dysfunction due to acute renal damage
chornic kidney disease	guideline recommended routine treatment	Chornic kidney injury caused by heart disease or cardiac dysfunction due to chronic kidney disease

Primary Outcome Measures

Name	Time	Method
Hospitalization due to worsening of renal or cardiac function	1 year	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
All-cause deaths	1 year	Deaths due to disease progression

Secondary Outcome Measures

Name	Time	Method
Acute kidney injury	1 year	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.
End-stage renal disease requires maintenance dialysis	1 year	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.