Cardorenal Syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 85 years; 2. Patients diagnosed with Type II cardio-renal syndrome according to Western medical criteria; 3. Patients diagnosed with qi deficiency and blood stasis syndrome according to traditional Chinese medicine (TCM) differentiation; 4. Patients with New York Heart Association (NYHA) cardiac functional classification of II-III grade; 5. Patients without mental disorders and able to cooperate with the investigation; 6. Volunteers willing to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who have had a cardiac resynchronization therapy device implanted or undergone cardiac resynchronization therapy within 12 weeks; 2. Those with acute coronary syndrome (within 30 days), cardiogenic shock, acute myocarditis, uncontrolled malignant arrhythmias, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, cardiac tamponade, severe valvular disease requiring surgical treatment, or pulmonary artery embolism; 3. Those with severe primary diseases of the heart, liver, kidneys, hematopoietic system, or metabolic system; those with malignant tumors, jaundice, or impaired liver or kidney function; 4. Those with acute infections; 5. Those who are positive for human immunodeficiency virus antibodies, syphilis, hepatitis B, or hepatitis C; 6. Those whose heart failure symptoms have worsened due to digoxin poisoning; 7. Women who are planning pregnancy, are pregnant, or are breastfeeding; 8. Those suspected of or confirmed to have alcohol or substance abuse; 9. Those with a history of allergies, allergies to two or more foods or medications, or allergies to the investigational drug or its excipients; 10. Those who have used traditional Chinese medicine to treat heart failure or renal failure within 2 weeks prior to enrollment; 11. Those who have participated in other studies within the past 2 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiac Function Classification; | — |
Secondary
| Measure | Time frame |
|---|---|
| N-terminal pro-B-type natriuretic peptide (NT-proBNP);Left Ventricular Ejection Fraction (LVEF);Left Ventricular Internal Diameter at End Diastole (LVIDd);The ratio of the peak velocity of early diastolic mitral inflow to the early diastolic mitral annulus velocity (E/e').;Serum Creatinine (Scr);Blood Urea Nitrogen (BUN);Cystatin C (Cys-C);Estimated Glomerular Filtration Rate (eGFR);TCM syndrome score;6-minute walk test;Minnesota Living with Heart Failure Questionnaire (MLHFQ); | — |
Countries
China
Contacts
Shuguang Anhui Hospital Affiliated to Shanghai University of Traditional Chinese Medicine