Dopamine in Acute Decompensated Heart Failure II
Information source: Larissa University Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Decompensated Heart Failure
Intervention: High-dose furosemide (Drug); Low-dose furosemide (Drug); Low-dose furosemide combined with low-dose dopamine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Larissa University Hospital Official(s) and/or principal investigator(s):
Gregory Giamouzis, MD, Study Chair, Affiliation: Department of Cardiology, Larissa University Hospital, Larissa, Greece
Filippos Triposkiadis, MD, Study Chair, Affiliation: Department of Cardiology, Larissa University Hospital, Larissa, Greece
Overall contact:
Gregory Giamouzis, MD, Phone: +30 6937212670, Email: ggiamou@emory.edu
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
Secondary outcome: 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)
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Gregory Giamouzis, MD, Phone: +30 6937212670, Email: ggiamou@emory.edu
Department of Cardiology and Pneumology, Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany; Not yet recruiting
Carsten Tschöpe, MD
Carsten Tschöpe, MD, Principal Investigator
Dirk Westermann, MD, Sub-Investigator
Konstantinos Savvatis, MD, Sub-Investigator
Department of Cardiology, Larissa University Hospital, Larissa 411 10, Greece; Recruiting
Gregory Giamouzis, MD, Phone: +30 6937212670, Email: ggiamou@emory.edu
Gregory Giamouzis, MD, Principal Investigator
Filippos Triposkiadis, MD, Principal Investigator
John Skoularigis, MD, Sub-Investigator
Dimitrios Economou, MD, Sub-Investigator
George Karayannis, MD, Sub-Investigator
Dimitrios Rovithis, MD, Sub-Investigator
Charalambos Parisis, MD, Sub-Investigator
AHEPA University Hospital, Thessaloniki, Greece; Recruiting
George Giannakoulas, MD
Haralambos Karvounis, MD, Principal Investigator
George Giannakoulas, MD, Sub-Investigator
Lilian Mantziari, MD, Sub-Investigator
First Department of Cardiology, University of Athens, Athens, Attiki, Greece; Recruiting
Christos Antoniou, MD
Christodoulos Stefanadis, MD, Principal Investigator
Christos Pitsavos, MD, Principal Investigator
Chris Antoniou, MD, Sub-Investigator
Christina Chrisochoou, MD, Sub-Investigator
Division of Cardiology, Emory University Hospital, Atlanta, Georgia, United States; Not yet recruiting
Javed Butler, MD, MPH
Javed Butler, MD, MPH, Principal Investigator
Andreas Kalogeropoulos, MD, Sub-Investigator
Vasiliki V. Georgiopoulou, MD, Sub-Investigator
Department of Cardiology, Volos General Hospital, Volos, Magnesia 382 21, Greece; Recruiting
Themistoklis Tsaknakis, MD
Themistoklis Tsaknakis, MD, Principal Investigator
John Nastas, MD, Sub-Investigator
Themistoklis Kirlidis, MD, Sub-Investigator
Theodora Karotsaki, MD, Sub-Investigator
The Cleveland Clinic Foundation, Cleveland, Ohio, United States; Not yet recruiting
Randal C. Starling, MD, MPH
Randal C. Starling, MD, MPH, Principal Investigator
Additional Information
Starting date: July 2009
Last updated: May 25, 2010
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