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

Primary Purpose

Acute Decompensated Heart Failure

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
High-dose furosemide
Low-dose furosemide
Low-dose furosemide combined with low-dose dopamine
Sponsored by
Larissa University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - undefined (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,
  • age >18 years old,
  • on medical therapy with an ACE-inhibitor and/or a β-blocker,
  • experiencing an acute decompensation of known chronic HF,
  • baseline oxygen saturation <90% on admission arterial blood gas

Exclusion Criteria:

  • 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

  • Division of Cardiology, Emory University Hospital
  • The Cleveland Clinic Foundation
  • First Department of Cardiology, University of Athens
  • Department of Cardiology, Volos General Hospital
  • Department of Cardiology, Larissa University Hospital
  • AHEPA University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

High-dose furosemide

Low-dose furosemide

Low-dose furosemide combined with low-dose dopamine

Arm Description

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

Low-dose furosemide (LDF): continuous IV administration of 5 mg/h 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

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).
Novel indices of acute renal ischemia/injury (cystatin-C, KIM-1, NGAL)

Full Information

First Posted
February 1, 2010
Last Updated
September 10, 2013
Sponsor
Larissa University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01060293
Brief Title
Dopamine in Acute Decompensated Heart Failure II
Acronym
DAD-HF II
Official Title
Comparison of High-dose Furosemide, Low-dose Furosemide, and 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
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Safety issues in the LDFD-group (higher heart rate with dopamine)
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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 1) high-dose furosemide, 2) low-dose furosemide, and 3) low-dose furosemide combined with low-dose dopamine on diuresis, clinical status, renal function, electrolyte balance, length of stay, and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart failure.
Detailed Description
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), low-dose furosemide (LDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 5 mg/h furosemide for a total of 8 hours), and 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, perceived dyspnea, renal function, electrolyte balance, total length of stay, 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 Decompensated 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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
161 (Actual)

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 furosemide
Arm Type
Active Comparator
Arm Description
Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide
Arm Title
Low-dose furosemide combined with low-dose dopamine
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)
High-dose furosemide
Intervention Description
High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours
Intervention Type
Drug
Intervention Name(s)
Low-dose furosemide
Intervention Description
Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide
Intervention Type
Drug
Intervention Name(s)
Low-dose furosemide combined with low-dose dopamine
Intervention 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
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-day post discharge
Title
Novel indices of acute renal ischemia/injury (cystatin-C, KIM-1, NGAL)
Time Frame
Throughout hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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, age >18 years old, on medical therapy with an ACE-inhibitor and/or a β-blocker, experiencing an acute decompensation of known chronic HF, baseline oxygen saturation <90% on admission arterial blood gas Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Giamouzis, MD
Organizational Affiliation
Department of Cardiology, Larissa University Hospital, Larissa, Greece
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Filippos Triposkiadis, MD
Organizational Affiliation
Department of Cardiology, Larissa University Hospital, Larissa, Greece
Official's Role
Study Chair
Facility Information:
Facility Name
Division of Cardiology, Emory University Hospital
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
First Department of Cardiology, University of Athens
City
Athens
State/Province
Attiki
Country
Greece
Facility Name
Department of Cardiology, Volos General Hospital
City
Volos
State/Province
Magnesia
ZIP/Postal Code
382 21
Country
Greece
Facility Name
Department of Cardiology, Larissa University Hospital
City
Larissa
ZIP/Postal Code
411 10
Country
Greece
Facility Name
AHEPA University Hospital
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
24485633
Citation
Triposkiadis FK, Butler J, Karayannis G, Starling RC, Filippatos G, Wolski K, Parissis J, Parisis C, Rovithis D, Koutrakis K, Skoularigis J, Antoniou CK, Chrysohoou C, Pitsavos C, Stefanadis C, Nastas J, Tsaknakis T, Mantziari L, Giannakoulas G, Karvounis H, Kalogeropoulos AP, Giamouzis G. Efficacy and safety of high dose versus low dose furosemide with or without dopamine infusion: the Dopamine in Acute Decompensated Heart Failure II (DAD-HF II) trial. Int J Cardiol. 2014 Mar 1;172(1):115-21. doi: 10.1016/j.ijcard.2013.12.276. Epub 2014 Jan 10.
Results Reference
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Dopamine in Acute Decompensated Heart Failure II

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