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

May 25, 2010 updated by: Larissa University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

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 Contact

Study Contact Backup

Study Locations

  • Greece
      • Larissa, Greece, 411 10
        • Recruiting
        • Department of Cardiology, Larissa University Hospital
        • 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
    • Magnesia
      • Volos, Magnesia, Greece, 382 21
        • Recruiting
        • Department of Cardiology, Volos General Hospital
        • Principal Investigator:
          • Themistoklis Tsaknakis, MD
        • Sub-Investigator:
          • John Nastas, MD
        • Sub-Investigator:
          • Themistoklis Kyrlidis, MD

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

16 years to 88 years (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
  • 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

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: Triple

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: 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)

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 days post discharge
60 days post discharge

Collaborators and Investigators

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

Sponsor

Larissa University Hospital

Investigators

  • Principal Investigator: Gregory Giamouzis, MD, Larissa University Hospital
  • Principal Investigator: Filippos Triposkiadis, MD, Larissa University Hospital

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

January 1, 2009

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

June 29, 2009

First Submitted That Met QC Criteria

July 9, 2009

First Posted (Estimate)

July 10, 2009

Study Record Updates

Last Update Posted (Estimate)

May 26, 2010

Last Update Submitted That Met QC Criteria

May 25, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUH-DC-101-FT

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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