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

This study has been terminated.
(Safety issues in the LDFD-group (higher heart rate with dopamine))
Sponsor:
Information provided by (Responsible Party):
Gregory Giamouzis, Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT01060293
First received: February 1, 2010
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Acute Decompensated Heart Failure
Drug: High-dose furosemide
Drug: Low-dose furosemide
Drug: Low-dose furosemide combined with low-dose dopamine
Phase 4

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

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-day post discharge ] [ Designated as safety issue: No ]
  • Novel indices of acute renal ischemia/injury (cystatin-C, KIM-1, NGAL) [ Time Frame: Throughout hospitalization ] [ Designated as safety issue: No ]

Enrollment: 161
Study Start Date: July 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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: 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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
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,
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060293

Locations
United States, Georgia
Division of Cardiology, Emory University Hospital
Atlanta, Georgia, United States
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Greece
First Department of Cardiology, University of Athens
Athens, Attiki, Greece
Department of Cardiology, Volos General Hospital
Volos, Magnesia, Greece, 382 21
Department of Cardiology, Larissa University Hospital
Larissa, Greece, 411 10
AHEPA University Hospital
Thessaloniki, Greece
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Gregory Giamouzis, Assistant Professor of Cardiology, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT01060293     History of Changes
Other Study ID Numbers: 3975
Study First Received: February 1, 2010
Last Updated: September 10, 2013
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
Heart Diseases
Cardiovascular Diseases
Dopamine
Dopamine Agents
Furosemide
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on April 15, 2014