We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01060293
First Posted: February 2, 2010
Last Update Posted: September 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gregory Giamouzis, Larissa University Hospital
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Gregory Giamouzis, 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 ]

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 ]
  • Novel indices of acute renal ischemia/injury (cystatin-C, KIM-1, NGAL) [ Time Frame: Throughout hospitalization ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gregory Giamouzis, Assistant Professor of Cardiology, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT01060293     History of Changes
Other Study ID Numbers: 3975
First Submitted: February 1, 2010
First Posted: February 2, 2010
Last Update Posted: September 11, 2013
Last Verified: September 2013

Keywords provided by Gregory Giamouzis, Larissa University Hospital:
Heart Failure
Dopamine
Furosemide
Worsening Renal Function
Hypokalemia
Outcomes
Prognosis

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Furosemide
Dopamine
Dopamine Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Neurotransmitter Agents
Protective Agents