Congestive Heart Failure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient must be more than 18 years old; 2. Acute decompensated HF within 24 h of hospital admission; 3. Fluid overload, defined as edema of the lower extremities and at least 1 of the following: 1) elevated jugular venous pressure > 10 cm H2O; 2) pulmonary rales, paroxysmal nocturnal dyspnea or orthopnea; 3) pulmonary edema or pleural effusion on chest X-ray; 4) enlarged liver or ascites; 5) pulmonary wedge or left ventricular end diastolic pressure = 20 mm Hg, or 6) rapid increase of body weight = 2 kg; 4. NYHA classification III-IV; 5. Patient is informed and has signed informed consent. Patient is willing to attend an outpatient follow-up.
Exclusion criteria
Exclusion criteria: 1. Acute coronary syndrome; 2. Severe mitral or aortic stenosis; 3. Severe renal insufficiency (serum creatinine = 3.0 mg/dl or eGFR = 30 mL/min); 4. Systolic blood pressure = 90 mmHg or depending on high dose of vasoactive drug to maintain systolic blood pressure = 90 mmHg; 5. Hematocrit > 45%; 6. Unattainable venous access; 7. Comorbidities expected to prolong hospitalization; 8. Contraindications to anticoagulation; 9. Serious bleeding in the last 6 months (this includes, but is not limited to, prior intracranial hemorrhage, active peptic ulcer disease, active internal bleeding, bleeding at a noncompressible site); 10. Bleeding diathesis within 30 days before randomization; 11. Patients at high risk of bleeding (this includes, but is not limited to, clinically significant thrombocytopenia or anemia, platelet count 180/110mmHg); 13. Severe infection; 14. Use of iodinated radiocontrast material; 15. Participation in another controlled clinical trial, either within the past 2 months or still ongoing; 16. Pregnant women, breast-feeding, or of child-bearing potential; 17. Patient with mentally ill.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the changes of weight loss;the changes of dyspnea severity score;the occurrence of clinically overt major bleeding; | — |
Secondary
| Measure | Time frame |
|---|---|
| net fluid loss;length of stay in CCU or ICU;change of score by MLWHFQ functional capacity;change of serum and ultrafiltrate concentrations of endotoxin,endothelin-1 (ET-1), tumor necrosis factor- (TNF-a), interleukin-6 (IL-6), and IL-10;worsening of cardiac function;changes in N-terminal proB-type natriuretic peptide (NT-proBNP) level;changes of diuretics dose;HF rehospitalizations for congestive HF in 30 days after discharge;cardiovascular death in 30 days after discharge;all-cause death in 30 days after discharge;change of blood pressure;hanges in hepatic and renal function (serum creatinine concentration, estimated glomerular filtration rate [eGFR]), serum electrolytes;change of hemoglobin;incidence of acute coronary symdrome; | — |
Countries
China
Contacts
Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University