Dopamine in Acute Decompensated Heart Failure II
- Conditions
- Acute Decompensated Heart Failure
- Interventions
- Registration Number
- NCT01060293
- Lead Sponsor
- Larissa University Hospital
- Brief Summary
The aim of this study is to compare the effects of 1) high-dose furosemide, 2) low-dose furosemide, and 3) low-dose furosemide combined with low-dose dopamine on diuresis, clinical status, renal function, electrolyte balance, length of stay, and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart failure.
- Detailed Description
The aim of this study is to compare the effects of:
1. high-dose furosemide (HDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 20 mg/h for a total of 8 hours),
2. low-dose furosemide (LDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 5 mg/h furosemide for a total of 8 hours), and
3. low-dose furosemide combined with low-dose dopamine (LDFD, 40 mg furosemide bolus IV, followed by continuous IV infusion of 5 mg/h furosemide plus 5μg/kg/min dopamine for a total of 8 hours) on diuresis, perceived dyspnea, renal function, electrolyte balance, total length of stay, and 60-day post-discharge outcomes in patients hospitalized with ADHF.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 161
- patients with New York Heart Association (NYHA) functional class IV heart failure according to the American Heart Association (AHA) classification, namely dyspnea on minimal exertion or rest dyspnea, orthopnea, and paroxysmal nocturnal dyspnea,
- signs of congestion (third heart sound or pulmonary rales on physical examination),
- pulmonary congestion on chest x-ray,
- serum B-type natriuretic peptide levels > 400 pg/ml or NT-proBNP > 1500 pg/ml,
- echocardiographic documentation of systolic or diastolic dysfunction,
- age >18 years old,
- on medical therapy with an ACE-inhibitor and/or a β-blocker,
- experiencing an acute decompensation of known chronic HF,
- baseline oxygen saturation <90% on admission arterial blood gas
- acute de novo HF;
- severe renal failure (serum creatinine >200 μmol/L or GFR <30 ml/min/1.73m2)
- admission systolic blood pressure <90 mm Hg;
- severe valvular disease;
- known adverse reactions to furosemide or dopamine;
- HF secondary to congenital heart disease;
- a scheduled procedure with a need for IV contrast dye;
- a scheduled cardiac surgery within 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low-dose furosemide combined with low-dose dopamine Low-dose furosemide combined with low-dose dopamine Low-dose furosemide combined with low-dose dopamine (LDFD): continuous IV administration of 5 mg/h furosemide combined with 5 μg/kg/min dopamine for a total of 8 hours High-dose furosemide High-dose furosemide High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours Low-dose furosemide Low-dose furosemide Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide
- Primary Outcome Measures
Name Time Method 1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure). 1-year
- Secondary Outcome Measures
Name Time Method 60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure). 60-day post discharge Novel indices of acute renal ischemia/injury (cystatin-C, KIM-1, NGAL) Throughout hospitalization
Trial Locations
- Locations (6)
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Division of Cardiology, Emory University Hospital
🇺🇸Atlanta, Georgia, United States
First Department of Cardiology, University of Athens
🇬🇷Athens, Attiki, Greece
Department of Cardiology, Larissa University Hospital
🇬🇷Larissa, Greece
AHEPA University Hospital
🇬🇷Thessaloniki, Greece
Department of Cardiology, Volos General Hospital
🇬🇷Volos, Magnesia, Greece