Effect of W-3 Polyunsaturated Fatty Acids on Serum Albumin Concentration in Patients With Acute Heart Failure, Hypoalbuminemia, and High Inflammatory Activity

Study Overview
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Brief Summary
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Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin

Detailed Description
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Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin Assess the effect of high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity on: Inflammatory activity (C-reactive protein) The development of biomarkers (NTproBNP). The prognosis of patients evaluated by the combined event of death from any cause or readmission for heart failure within three months after randomization.

Official Title
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Effect of W-3 Polyunsaturated Fatty Acids on Serum Albumin Concentration in Patients With Acute Heart Failure, Hypoalbuminemia, and High Inflammatory Activity

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Polyunsaturated fatty acids omega-3
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years or olders hospitalized for acute heart failure, chronic decompensated or new onset of any etiology, presenting hypoalbuminemia (serum albumin ?3,4 g / dl) and high inflammatory activity (CRP ?2,5 mg / dl). Exclusion Criteria: Impending doom Participating in other clinical trials Treatment with ?-3 acids in the last month prior to admission Percutaneous or surgical treatment of the cause of heart failure during hospitalization. Pregnant women. Renal failure on dialysis. Chronic liver disease Child-Pugh B or C. Acute infectious process. Active malignant neoplasia.

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 |
| --- | --- |
| Experimental: Intervention<br>4 daily capsules of polyunsaturated fatty acids omega-3, during 4 weeks. Each capsule contains: 460 mg eicosapentaenoic acid ethyl ester and 380 mg docosahexaenoic acid ethyl ester. | Drug: Polyunsaturated fatty acids omega-3<br>* 4 daily capsules of polyunsaturated fatty acids omega-3, during 4 weeks. Each capsule contains: 460 mg eicosapentaenoic acid ethyl ester and 380 mg docosahexaenoic acid ethyl ester.<br>|
| Placebo Comparator: Control<br>Capsules of similar appearance and flavor without active drug | Drug: Placebo<br>* 4 daily capsules of similar appearance and flavor without active ingredient<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum albumin levels | Serum albumin levels in the fourth week | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein levels | C-reactive protein levels in the fourth week | Four weeks | 
| NTproBNP levels | NTproBNP levels in the fourth week | Four weeks | 
| Combined event of death from any cause or readmission for heart failure | Combined event of death from any cause or readmission for heart failure within three months after randomization | Three months |