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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Heart Failure

Intervention / Treatment
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* Drug: Furosemide
* Drug: low-dose dopamine + low-dose furosemide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High-dose furosemide<br>High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours | Drug: Furosemide<br>* High-dose furosemide(HDF, furosemide 20 mg/h intravenously)<br>|
| Active Comparator: low-dose dopamine + low-dose furosemide<br>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 | Drug: low-dose dopamine + low-dose furosemide<br>* low-dose furosemide combined with low-dose dopamine (LDFD, furosemide 5 mg/h plus dopamine 5μg/kg/min intravenously)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure). |  | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure). |  | 60 days post discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Dopamine, Furosemide, Worsening Renal Function, Hypokalemia, Outcomes, Prognosis