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

Hospital San Juan de la Cruz

Status and phase: Completed; Phase 3

Conditions: Heart Failure

Treatments: Drug: Polyunsaturated fatty acids omega-3; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02708771

HSJC-CAR-01-2015

Details and patient eligibility

About

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

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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.

Treatment:

Drug: Polyunsaturated fatty acids omega-3

Control

Placebo Comparator group

Description:

Capsules of similar appearance and flavor without active drug

Treatment:

Drug: Placebo