Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial
Information source: Larissa University Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Heart Failure
Intervention: Furosemide (Drug); low-dose dopamine + low-dose furosemide (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Larissa University Hospital Official(s) and/or principal investigator(s):
Gregory Giamouzis, MD, Principal Investigator, Affiliation: Larissa University Hospital
Filippos Triposkiadis, MD, Principal Investigator, Affiliation: Larissa University Hospital
Overall contact:
Filippos Triposkiadis, MD, Phone: +30 2410682821, Email: ftriposkiadis@yahoo.com
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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).
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
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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
Locations and Contacts
Filippos Triposkiadis, MD, Phone: +30 2410682821, Email: ftriposkiadis@yahoo.com
Department of Cardiology, Larissa University Hospital, Larissa 411 10, Greece; Recruiting
Gregory Giamouzis, MD, Principal Investigator
Filippos Triposkiadis, MD, Principal Investigator
John Skoularigis, MD, Sub-Investigator
Dimitrios Economou, MD, Sub-Investigator
George Karayannis, MD, Sub-Investigator
Dimitrios Rovithis, MD, Sub-Investigator
Charalambos Parisis, MD, Sub-Investigator
Department of Cardiology, Volos General Hospital, Volos, Magnesia 382 21, Greece; Recruiting
Themistoklis Tsaknakis, MD, Principal Investigator
John Nastas, MD, Sub-Investigator
Themistoklis Kyrlidis, MD, Sub-Investigator
Additional Information
Starting date: January 2009
Ending date: July 2012
Last updated: September 25, 2009
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