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

Phase 4

• Conditions: Acute Heart Failure
• Interventions: Drug: low-dose dopamine + low-dose furosemide; Drug: Furosemide

• Registration Number: NCT00937092
• Lead Sponsor: Larissa University Hospital

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.

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-07-09
• Study First Posted: 2009-07-10
• Primary Completion: 2010-01
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-25
• Last Update Posted: 2010-05-26
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low-dose dopamine + low-dose furosemide	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
High-dose furosemide	Furosemide	High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Department of Cardiology, Volos General Hospital; 🇬🇷 Volos, Magnesia, Greece

Department of Cardiology, Larissa University Hospital; 🇬🇷 Larissa, Greece