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NCT Number: NCT05397392

Research on Optimal Diagnosis and Treatment of Cardiorenal Syndrome

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

guideline recommended routine treatment

Other

Primary outcomes

  1. Hospitalization due to worsening of renal or cardiac function

    Time frame: 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

  2. All-cause deaths

    Time frame: 1 year

    Deaths due to disease progression

Secondary outcomes

  1. End-stage renal disease requires maintenance dialysis

    Time frame: 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.

  2. Acute kidney injury

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiao-xia Chen, master of medicine

CONTACT

[email protected]

+8615380998950

Yue Zhou, master of medicine

CONTACT

[email protected]

+8615380998793

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Acronym: ODT-CRS

Important dates

Study start
2016
Primary completion
2026
Study completion
2027
First posted
May 31, 2022
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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