Acute Decompensated Heart Failure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of Acute HF At least 1 symptom (dyspnea, orthopnea, or edema) At least 1 sign (rales, edema, ascites, chest radiographic signs of HF) Enrolled within 6 hours of hospital admission Age above 20, below 85 years Systolic BP 100 mmHg and above Willingness to provide written informed consent
Exclusion criteria
Exclusion criteria: No indication of intravenous vasodilators or diuretics for initial treatments Carperitide administration before randomization Receiving dialysis eGFR less than 15 mL/min/1.73m2 Acute coronary syndrome Possible for pregnancy Enrolled other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of all-cause death and HF hospitalization events of HF hospitalizations must have clinical manifestations of worsening HF (new or worsening dyspnea, orthopnea, paroxysmal nocturnal dyspnea, edema, pulmonary basilar rales/crackles, jugular venous distension, renal hypoperfusion with no other apparent cause, or radiological evidence of worsening HF) and additional/increased therapy, specifically for the treatment of worsening HF with at least one of the following: 1. Intravenous treatment with a diuretic, inotropic, vasodilator, or other recognized intravenous HF treatment 2. Mechanical or surgical intervention (mechanical circulatory support) or the use of ultrafiltration, hemofiltration, or dialysis specifically directed at treatment of HF | — |
Secondary
| Measure | Time frame |
|---|---|
| Decongestion Cumulative urinary volume at 72 h Urinary sodium excretion at 72 h Change in body weight from randomization to 72 h Symptom relief Change in degree of dyspnea assessed by area under the curve of visual analogue scale over 72 h Renal function Change in eGFR from randomization to 72 h Serum cystatin-C level from randomization to 72 h Biomarkers Change in plasma brain natriuretic peptide, renin, aldosterone, dopamine, adrenaline and noradrenaline levels, and serum sodium, potassium, chloride and neutrophil gelatinase-associated lipocalin levels from randomization to 72 h | — |
Countries
Japan
Contacts
Hokkaido University Cardiovascular Medicine