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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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


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
Active Comparator: High-dose furosemide
High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours
Drug: Furosemide
High-dose furosemide(HDF, furosemide 20 mg/h intravenously)
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Volos General Hospital Recruiting
Volos, Magnesia, Greece, 382 21
Principal Investigator: Themistoklis Tsaknakis, MD         
Sub-Investigator: John Nastas, MD         
Sub-Investigator: Themistoklis Kyrlidis, MD         
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         
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 by Larissa University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gregory Giamouzis, MD, Department of Cardiology, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT00937092     History of Changes
Other Study ID Numbers: LUH-DC-101-FT
Study First Received: June 29, 2009
Last Updated: May 25, 2010
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:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Dopamine
Dopamine Agents
Furosemide
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sodium Potassium Chloride Symporter Inhibitors
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014