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

Hospital San Juan de la Cruz42 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Heart Failure

Interventions

Polyunsaturated fatty acids omega-3DRUG

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.

PlaceboDRUG

4 daily capsules of similar appearance and flavor without active ingredient

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital San Juan de la Cruz

Úbeda, Jaen, Spain

Outcomes

Primary Outcomes

Serum albumin levels

Serum albumin levels in the fourth week

Time frame: Four weeks

Secondary Outcomes

C-reactive protein levels

C-reactive protein levels in the fourth week

Time frame: Four weeks

NTproBNP levels

NTproBNP levels in the fourth week

Time frame: 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

Time frame: Three months

Data from ClinicalTrials.gov

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