Effect of Low-Dose Carperitide in Patients With Acute Decompensated Heart Failure The Randomized Trial (Low-dose AdminiStration of CARperitide for Acute Heart Failure:LASCAR-AHF study)
Not Applicable
- Conditions
- Acute Decompensated Heart Failure
- Registration Number
- JPRN-UMIN000013819
- Lead Sponsor
- ational Cerebral and Cardiovascular Center, Division of Cardiovascular Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 260
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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