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

Larissa University Hospital

Status and phase: Terminated; Phase 4

Conditions: Acute Decompensated Heart Failure

Treatments: Drug: Low-dose furosemide; Drug: Low-dose furosemide combined with low-dose dopamine; Drug: High-dose furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT01060293

3975

Details and patient eligibility

About

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.

Full 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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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,
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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161 participants in 3 patient groups

High-dose furosemide

Active Comparator group

Description:

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

Treatment:

Drug: High-dose furosemide

Low-dose furosemide

Active Comparator group

Description:

Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide

Treatment:

Drug: Low-dose furosemide

Low-dose furosemide combined with low-dose dopamine

Active Comparator group

Description:

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

Treatment:

Drug: Low-dose furosemide combined with low-dose dopamine