Acute Heart Failure | Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial
Acute Heart Failure research study
What is the primary objective of this study?
The aim of this study is to compare the effects of high-dose furosemide versus low-dose furosemide combined with low-dose dopamine on diuresis, renal function, electrolyte balance, and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart failure.
Who is eligible to participate?
Inclusion Criteria: - 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 - all candidate patients must be: - Age >18 years old - on medical therapy with an ACE-inhibitor and/or a β-blocker - experiencing an acute decompensation of known chronic HF - Having baseline oxygen saturation <90% on admission arterial blood gas Exclusion Criteria: - the investigators will exclude patients with: - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Acute Heart Failure
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:FurosemideHigh-dose furosemide(HDF, furosemide 20 mg/h intravenously)
Drug:low-dose dopamine + low-dose furosemidelow-dose furosemide combined with low-dose dopamine (LDFD, furosemide 5 mg/h plus dopamine 5μg/kg/min intravenously)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
High-dose furosemideHigh-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours
low-dose dopamine + low-dose furosemideLow-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
Start Date: January 2009
Completed Date: July 2012
Phase: Phase 4
Primary Outcome: 1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
Secondary Outcome: 60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
Study sponsors, principal investigator, and references
Principal Investigator: Gregory Giamouzis, MD
Lead Sponsor: Larissa University Hospital