Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial - Full Text View

Sponsor:	Larissa University Hospital
Information provided by:	Larissa University Hospital
ClinicalTrials.gov Identifier:	NCT00937092

Purpose

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.

Condition	Intervention	Phase
Acute Heart Failure	Drug: Furosemide Drug: low-dose dopamine + low-dose furosemide	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Dopamine Furosemide Dopamine hydrochloride

U.S. FDA Resources

Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:

1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure). [ Time Frame: 1-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure). [ Time Frame: 60 days post discharge ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	January 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
High-dose furosemide: Active Comparator High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours	Drug: Furosemide High-dose furosemide(HDF, furosemide 20 mg/h intravenously)
low-dose dopamine + low-dose furosemide: Active Comparator 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	Drug: low-dose dopamine + low-dose furosemide low-dose furosemide combined with low-dose dopamine (LDFD, furosemide 5 mg/h plus dopamine 5μg/kg/min intravenously)

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

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937092

Contacts

Contact: Filippos Triposkiadis, MD	+30 2410682821	ftriposkiadis@yahoo.com
Contact: Gregory Giamouzis, MD	+30 6937212670	ggiamou@emory.edu

Locations

Greece
Department of Cardiology, Larissa University Hospital	Recruiting
Larissa, Greece, 411 10
Principal Investigator: Gregory Giamouzis, MD
Principal Investigator: Filippos Triposkiadis, MD
Sub-Investigator: John Skoularigis, MD
Sub-Investigator: Dimitrios Economou, MD
Sub-Investigator: George Karayannis, MD
Sub-Investigator: Dimitrios Rovithis, MD
Sub-Investigator: Charalambos Parisis, MD
Greece, Magnesia
Department of Cardiology, Volos General Hospital	Recruiting
Volos, Magnesia, Greece, 382 21
Principal Investigator: Themistoklis Tsaknakis, MD
Sub-Investigator: John Nastas, MD
Sub-Investigator: Themistoklis Kyrlidis, MD

Sponsors and Collaborators

Larissa University Hospital

Investigators

Principal Investigator:	Gregory Giamouzis, MD	Larissa University Hospital
Principal Investigator:	Filippos Triposkiadis, MD	Larissa University Hospital

More Information

No publications provided

Responsible Party:	Department of Cardiology, Larissa University Hospital ( Gregory Giamouzis, MD )
Study ID Numbers:	LUH-DC-101-FT
Study First Received:	June 29, 2009
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00937092 History of Changes
Health Authority:	Greece: Ministry of Health and Welfare

Keywords provided by Larissa University Hospital:

Heart Failure
Dopamine
Furosemide
Worsening Renal Function

Hypokalemia
Outcomes
Prognosis

Additional relevant MeSH terms:

Neurotransmitter Agents
Heart Failure
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Sympathomimetics
Diuretics
Physiological Effects of Drugs
Cardiovascular Agents
Protective Agents
Furosemide

Pharmacologic Actions
Membrane Transport Modulators
Dopamine
Natriuretic Agents
Autonomic Agents
Therapeutic Uses
Cardiovascular Diseases
Dopamine Agents
Peripheral Nervous System Agents
Sodium Potassium Chloride Symporter Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010