Clinical trial NCT01060293: Dopamine in Acute Decompensated Heart Failure 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Decompensated Heart Failure
Keywords: Heart Failure
Dopamine
Furosemide
Worsening Renal Function
Hypokalemia
Outcomes
Prognosis
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 β-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

Primary outcomes:
measure: 1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
timeFrame: 1-year
Secondary outcomes:
measure: 60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
timeFrame: 60-day post discharge
measure: Novel indices of acute renal ischemia/injury (cystatin-C, KIM-1, NGAL)
timeFrame: Throughout hospitalization
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Division of Cardiology, Emory University Hospital
state: Georgia
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Athens
country: Greece
facility: First Department of Cardiology, University of Athens
state: Attiki
city: Volos
country: Greece
facility: Department of Cardiology, Volos General Hospital
state: Magnesia
city: Larissa
country: Greece
facility: Department of Cardiology, Larissa University Hospital
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital
Study officials:
affiliation: Department of Cardiology, Larissa University Hospital, Larissa, Greece
name: Gregory Giamouzis, MD
role: STUDY_CHAIR
affiliation: Department of Cardiology, Larissa University Hospital, Larissa, Greece
name: Filippos Triposkiadis, MD
role: STUDY_CHAIR
References:
citation: Triposkiadis FK, Butler J, Karayannis G, Starling RC, Filippatos G, Wolski K, Parissis J, Parisis C, Rovithis D, Koutrakis K, Skoularigis J, Antoniou CK, Chrysohoou C, Pitsavos C, Stefanadis C, Nastas J, Tsaknakis T, Mantziari L, Giannakoulas G, Karvounis H, Kalogeropoulos AP, Giamouzis G. Efficacy and safety of high dose versus low dose furosemide with or without dopamine infusion: the Dopamine in Acute Decompensated Heart Failure II (DAD-HF II) trial. Int J Cardiol. 2014 Mar 1;172(1):115-21. doi: 10.1016/j.ijcard.2013.12.276. Epub 2014 Jan 10.