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

Sponsor

Larissa University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00937092

Collaborator

(none)

300

Enrollment

Locations

Arms

Duration (Months)

150

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Heart Failure	Drug: Furosemide Drug: low-dose dopamine + low-dose furosemide	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2009

Anticipated Primary Completion Date :

Jan 1, 2010

Anticipated Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: High-dose furosemide High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours	Drug: Furosemide High-dose furosemide(HDF, furosemide 20 mg/h intravenously)
Active Comparator: 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	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)

Arm

Intervention/Treatment

Active Comparator: High-dose furosemide

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

Drug: Furosemide

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

Active Comparator: 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

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)

Outcome Measures

Primary Outcome Measures

1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure). [1-year]

Secondary Outcome Measures

60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure). [60 days post discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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