Dopamine in Acute Decompensated Heart Failure II

Acute Decompensated Heart Failure Clinical Trial

— DAD-HF II  

Official title:

Comparison of High-dose Furosemide, Low-dose Furosemide, and the Combination of Low-dose Furosemide and Low-dose Dopamine in Patients With Acute Decompensated Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01060293
• Other study ID #: 3975
• Status: Terminated
• Phase: Phase 4
• First received: February 1, 2010
• Last updated: September 10, 2013
• Start date: July 2009
• Est. completion date: December 2013

Study information

• Verified date: September 2013
• Source: Larissa University Hospital
• Contact: n/a
• 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 161
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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,

• age >18 years old,

• on medical therapy with an ACE-inhibitor and/or a ß-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

Study Design

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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

Drug:
• High-dose furosemide
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
• 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

Locations

Country	Name	City	State
Greece	First Department of Cardiology, University of Athens	Athens	Attiki
Greece	Department of Cardiology, Larissa University Hospital	Larissa
Greece	AHEPA University Hospital	Thessaloniki
Greece	Department of Cardiology, Volos General Hospital	Volos	Magnesia
United States	Division of Cardiology, Emory University Hospital	Atlanta	Georgia
United States	The Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Larissa University Hospital

Countries where clinical trial is conducted

United States,  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-day post discharge	No
Secondary	Novel indices of acute renal ischemia/injury (cystatin-C, KIM-1, NGAL)		Throughout hospitalization	No