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

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants 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

Furosemide

Intervention Type DRUG

High-dose furosemide(HDF, furosemide 20 mg/h intravenously)

low-dose dopamine + low-dose furosemide

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 dopamine + low-dose furosemide

Intervention Type DRUG

low-dose furosemide combined with low-dose dopamine (LDFD, furosemide 5 mg/h plus dopamine 5μg/kg/min intravenously)

Interventions

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Furosemide

High-dose furosemide(HDF, furosemide 20 mg/h intravenously)

Intervention Type DRUG

low-dose dopamine + low-dose furosemide

low-dose furosemide combined with low-dose dopamine (LDFD, furosemide 5 mg/h plus dopamine 5μg/kg/min intravenously)

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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No