Dopamine in Acute Decompensated Heart Failure II

Study Overview
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Brief Summary
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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
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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), 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 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.

Official Title
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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

Conditions
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Acute Decompensated Heart Failure

Intervention / Treatment
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* Drug: High-dose furosemide
* Drug: Low-dose furosemide
* Drug: Low-dose furosemide combined with low-dose dopamine


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, 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

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


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: High-dose furosemide<br>* High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours<br>|
| Active Comparator: Low-dose furosemide<br>Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide | Drug: Low-dose furosemide<br>* Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide<br>|
| Active Comparator: Low-dose furosemide combined with low-dose dopamine<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 furosemide combined with low-dose dopamine<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<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-day post discharge | 
| Novel indices of acute renal ischemia/injury (cystatin-C, KIM-1, NGAL) |  | Throughout hospitalization | 

 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