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

Acute Heart Failure Clinical Trial

— DAD-HF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00937092
• Other study ID #: LUH-DC-101-FT
• Status: Recruiting
• Phase: Phase 4
• First received: June 29, 2009
• Last updated: May 25, 2010
• Start date: January 2009
• Est. completion date: July 2012

Study information

• Verified date: May 2010
• Source: Larissa University Hospital
• Contact: Filippos Triposkiadis, MD
• Phone: +30 2410682821
• Email: ftriposkiadis[@]yahoo.com
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 2012
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 ß-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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Drug:
• Furosemide
High-dose furosemide(HDF, furosemide 20 mg/h intravenously)
• 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)

Locations

Country	Name	City	State
Greece	Department of Cardiology, Larissa University Hospital	Larissa
Greece	Department of Cardiology, Volos General Hospital	Volos	Magnesia

Sponsors (1)

Lead Sponsor	Collaborator
Larissa University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).		1-year	No
Secondary	60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).		60 days post discharge	No