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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Larissa University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT00937092
First received: June 29, 2009
Last updated: May 25, 2010
Last verified: May 2010

June 29, 2009
May 25, 2010
January 2009
January 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00937092 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial
Comparison of High-dose Furosemide Versus the Combination of Low-dose Furosemide and Low-dose Dopamine in Patients With Acute Decompensated Heart Failure

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Heart Failure
  • Drug: Furosemide
    High-dose furosemide(HDF, furosemide 20 mg/h intravenously)
  • 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)
  • Active Comparator: High-dose furosemide
    High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours
    Intervention: Drug: Furosemide
  • Active Comparator: low-dose dopamine + low-dose furosemide
    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
    Intervention: Drug: low-dose dopamine + low-dose furosemide
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, Tschöpe 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
July 2012
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact: Filippos Triposkiadis, MD +30 2410682821 ftriposkiadis@yahoo.com
Contact: Gregory Giamouzis, MD +30 6937212670 ggiamou@emory.edu
Greece
 
NCT00937092
LUH-DC-101-FT
No
Gregory Giamouzis, MD, Department of Cardiology, Larissa University Hospital
Larissa University Hospital
Not Provided
Principal Investigator: Gregory Giamouzis, MD Larissa University Hospital
Principal Investigator: Filippos Triposkiadis, MD Larissa University Hospital
Larissa University Hospital
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP