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

Primary Purpose

Acute Heart Failure

Status
Unknown status
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Furosemide
low-dose dopamine + low-dose furosemide
Sponsored by
Larissa University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Heart Failure focused on measuring Heart Failure, Dopamine, Furosemide, Worsening Renal Function, Hypokalemia, Outcomes, Prognosis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiology, Volos General HospitalRecruiting
  • Department of Cardiology, Larissa University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High-dose furosemide

low-dose dopamine + low-dose furosemide

Arm Description

High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours

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

Outcomes

Primary Outcome Measures

1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).

Secondary Outcome Measures

60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).

Full Information

First Posted
June 29, 2009
Last Updated
May 25, 2010
Sponsor
Larissa University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00937092
Brief Title
Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial
Acronym
DAD-HF
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

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Larissa University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
Keywords
Heart Failure, Dopamine, Furosemide, Worsening Renal Function, Hypokalemia, Outcomes, Prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-dose furosemide
Arm Type
Active Comparator
Arm Description
High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours
Arm Title
low-dose dopamine + low-dose furosemide
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Furosemide
Intervention Description
High-dose furosemide(HDF, furosemide 20 mg/h intravenously)
Intervention Type
Drug
Intervention Name(s)
low-dose dopamine + low-dose furosemide
Intervention Description
low-dose furosemide combined with low-dose dopamine (LDFD, furosemide 5 mg/h plus dopamine 5μg/kg/min intravenously)
Primary Outcome Measure Information:
Title
1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
Time Frame
1-year
Secondary Outcome Measure Information:
Title
60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
Time Frame
60 days post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Filippos Triposkiadis, MD
Phone
+30 2410682821
Email
ftriposkiadis@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory Giamouzis, MD
Phone
+30 6937212670
Email
ggiamou@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Giamouzis, MD
Organizational Affiliation
Larissa University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Filippos Triposkiadis, MD
Organizational Affiliation
Larissa University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Volos General Hospital
City
Volos
State/Province
Magnesia
ZIP/Postal Code
382 21
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Themistoklis Tsaknakis, MD
First Name & Middle Initial & Last Name & Degree
John Nastas, MD
First Name & Middle Initial & Last Name & Degree
Themistoklis Kyrlidis, MD
Facility Name
Department of Cardiology, Larissa University Hospital
City
Larissa
ZIP/Postal Code
411 10
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Giamouzis, MD
First Name & Middle Initial & Last Name & Degree
Filippos Triposkiadis, MD
First Name & Middle Initial & Last Name & Degree
John Skoularigis, MD
First Name & Middle Initial & Last Name & Degree
Dimitrios Economou, MD
First Name & Middle Initial & Last Name & Degree
George Karayannis, MD
First Name & Middle Initial & Last Name & Degree
Dimitrios Rovithis, MD
First Name & Middle Initial & Last Name & Degree
Charalambos Parisis, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21111980
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.
Results Reference
derived

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

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