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

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 Heart Failure

Intervention: Furosemide (Drug); low-dose dopamine + low-dose furosemide (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Larissa University Hospital

Official(s) and/or principal investigator(s):
Gregory Giamouzis, MD, Principal Investigator, Affiliation: Larissa University Hospital
Filippos Triposkiadis, MD, Principal Investigator, Affiliation: Larissa University Hospital

Overall contact:
Filippos Triposkiadis, MD, Phone: +30 2410682821, Email: ftriposkiadis@yahoo.com

Summary

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.

Clinical Details

Official title: Comparison of High-dose Furosemide Versus 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, 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).

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.

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. 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

- 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

Locations and Contacts

Filippos Triposkiadis, MD, Phone: +30 2410682821, Email: ftriposkiadis@yahoo.com

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

Department of Cardiology, Volos General Hospital, Volos, Magnesia 382 21, Greece; Recruiting
Themistoklis Tsaknakis, MD, Principal Investigator
John Nastas, MD, Sub-Investigator
Themistoklis Kyrlidis, MD, Sub-Investigator

Additional Information

Starting date: January 2009
Last updated: May 25, 2010

Page last updated: August 23, 2015

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