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

September 10, 2013 updated by: Gregory Giamouzis, Larissa University Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to compare the effects of:

  1. high-dose furosemide (HDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 20 mg/h for a total of 8 hours),
  2. 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
  3. 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.

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Larissa, Greece, 411 10
        • Department of Cardiology, Larissa University Hospital
      • Thessaloniki, Greece
        • Ahepa University Hospital
    • Attiki
      • Athens, Attiki, Greece
        • First Department of Cardiology, University of Athens
    • Magnesia
      • Volos, Magnesia, Greece, 382 21
        • Department of Cardiology, Volos General Hospital
  • United States
    • Georgia
      • Atlanta, Georgia, United States
        • Division of Cardiology, Emory University Hospital
    • Ohio
      • Cleveland, Ohio, United States
        • The Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High-dose furosemide
High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours
Drug: High-dose furosemide
High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours
Active Comparator: Low-dose furosemide
Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide
Drug: Low-dose furosemide
Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide
Active Comparator: Low-dose furosemide combined with low-dose dopamine
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 furosemide combined with low-dose dopamine
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
Time Frame: 60-day post discharge
60-day post discharge
Novel indices of acute renal ischemia/injury (cystatin-C, KIM-1, NGAL)
Time Frame: Throughout hospitalization
Throughout hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Larissa University Hospital

Investigators

  • Study Chair: Gregory Giamouzis, MD, Department of Cardiology, Larissa University Hospital, Larissa, Greece
  • Study Chair: Filippos Triposkiadis, MD, Department of Cardiology, Larissa University Hospital, Larissa, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (Estimate)

February 2, 2010

Study Record Updates

Last Update Posted (Estimate)

September 11, 2013

Last Update Submitted That Met QC Criteria

September 10, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3975

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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