Research on Optimal Diagnosis and Treatment of Cardiorenal Syndrome

Heart Failure Clinical Trial

— ODT-CRS  

Official title:

Research on Optimal Diagnosis and Treatment of Cardiorenal Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05397392
• Other study ID #: KY20220425-02
• Status: Recruiting
• Start date: January 2016
• Est. completion date: December 2027

Study information

• Verified date: April 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Yue Zhou, master of medicine
• Phone: +8615380998793
• Email: 56005460[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardio-Renal Syndrome
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Dialysis; Complications
• Heart Diseases
• Heart Failure
• Heart Valve Diseases
• Kidney Diseases
• Kidney Injury
• Myocardial Ischemia

Intervention

Other:
• guideline recommended routine treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	All-cause deaths	Deaths due to disease progression	1 year
Secondary	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.	1 year
Secondary	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.	1 year