Heart Failure Clinical Trial
— ODT-CRSOfficial title:
Research on Optimal Diagnosis and Treatment of Cardiorenal Syndrome
NCT number | NCT05397392 |
Other study ID # | KY20220425-02 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | December 2027 |
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
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Nanjing First Hospital, Nanjing Medical University |
China,
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 |
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