Clinical trial NCT00937092: Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial
Official title: Comparison of High-dose Furosemide Versus the Combination of Low-dose Furosemide and Low-dose Dopamine in Patients With Acute Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Heart Failure
Keywords: Heart Failure
Dopamine
Furosemide
Worsening Renal Function
Hypokalemia
Outcomes
Prognosis
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2009-07-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Worsening renal function (WRF) and hypokalemia related to diuretic use for acute decompensated heart failure (ADHF) are common and portend poor prognosis. Low dose dopamine infusion improves renal perfusion. Whether dopamine infusion improves diuresis and/or reduces renal complication in ADHF is not known. The aim of this study is to compare the effects of high-dose furosemide (HDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 20 mg/h for a total of 8 hours) vs. 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, renal function, electrolyte balance, and 60-day post-discharge outcomes in patients hospitalized with ADHF.

Eligibility criteria: 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

Primary outcomes:
measure: 1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
timeFrame: 1-year
Secondary outcomes:
measure: 60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
timeFrame: 60 days post discharge
Other outcomes:
Locations:
city: Volos
country: Greece
facility: Department of Cardiology, Volos General Hospital
state: Magnesia
city: Larissa
country: Greece
facility: Department of Cardiology, Larissa University Hospital
Study officials:
affiliation: Larissa University Hospital
name: Gregory Giamouzis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Larissa University Hospital
name: Filippos Triposkiadis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giamouzis G, Butler J, Starling RC, Karayannis G, Nastas J, Parisis C, Rovithis D, Economou D, Savvatis K, Kirlidis T, Tsaknakis T, Skoularigis J, Westermann D, Tschope C, Triposkiadis F. Impact of dopamine infusion on renal function in hospitalized heart failure patients: results of the Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial. J Card Fail. 2010 Dec;16(12):922-30. doi: 10.1016/j.cardfail.2010.07.246.