Dopamine in Acute Decompensated Heart Failure II

NCT ID: NCT01060293

Last Updated: 2013-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Decompensated Heart Failure

Keywords

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Heart Failure Dopamine Furosemide Worsening Renal Function Hypokalemia Outcomes Prognosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High-dose furosemide

High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours

Group Type ACTIVE_COMPARATOR

High-dose furosemide

Intervention Type DRUG

High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours

Low-dose furosemide

Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide

Group Type ACTIVE_COMPARATOR

Low-dose furosemide

Intervention Type DRUG

Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide

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

Group Type ACTIVE_COMPARATOR

Low-dose furosemide combined with low-dose dopamine

Intervention Type DRUG

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

Interventions

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High-dose furosemide

High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours

Intervention Type DRUG

Low-dose furosemide

Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Larissa University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gregory Giamouzis

Assistant Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregory Giamouzis, MD

Role: STUDY_CHAIR

Department of Cardiology, Larissa University Hospital, Larissa, Greece

Filippos Triposkiadis, MD

Role: STUDY_CHAIR

Department of Cardiology, Larissa University Hospital, Larissa, Greece

Locations

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Division of Cardiology, Emory University Hospital

Atlanta, Georgia, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

First Department of Cardiology, University of Athens

Athens, Attica, Greece

Site Status

Department of Cardiology, Larissa University Hospital

Larissa, Larissa, Greece

Site Status

Department of Cardiology, Volos General Hospital

Volos, Magnesia, Greece

Site Status

AHEPA University Hospital

Thessaloniki, Thessaloniki, Greece

Site Status

Countries

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Germany United States Greece

References

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Triposkiadis FK, Butler J, Karayannis G, Starling RC, Filippatos G, Wolski K, Parissis J, Parisis C, Rovithis D, Koutrakis K, Skoularigis J, Antoniou CK, Chrysohoou C, Pitsavos C, Stefanadis C, Nastas J, Tsaknakis T, Mantziari L, Giannakoulas G, Karvounis H, Kalogeropoulos AP, Giamouzis G. Efficacy and safety of high dose versus low dose furosemide with or without dopamine infusion: the Dopamine in Acute Decompensated Heart Failure II (DAD-HF II) trial. Int J Cardiol. 2014 Mar 1;172(1):115-21. doi: 10.1016/j.ijcard.2013.12.276. Epub 2014 Jan 10.

Reference Type DERIVED
PMID: 24485633 (View on PubMed)

Other Identifiers

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3975

Identifier Type: -

Identifier Source: org_study_id