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Dopamine in Acute Decompensated Heart Failure II

Information source: Larissa University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
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: Terminated

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

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

Department of Cardiology, Larissa University Hospital, Larissa 411 10, Greece

AHEPA University Hospital, Thessaloniki, Greece

First Department of Cardiology, University of Athens, Athens, Attiki, Greece

Division of Cardiology, Emory University Hospital, Atlanta, Georgia, United States

Department of Cardiology, Volos General Hospital, Volos, Magnesia 382 21, Greece

The Cleveland Clinic Foundation, Cleveland, Ohio, United States

Additional Information

Starting date: July 2009
Last updated: September 10, 2013

Page last updated: August 23, 2015

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