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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-06-30

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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Polyunsaturated fatty acids omega-3

Intervention Type DRUG

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.

Control

Capsules of similar appearance and flavor without active drug

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

4 daily capsules of similar appearance and flavor without active ingredient

Interventions

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Polyunsaturated fatty acids omega-3

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.

Intervention Type DRUG

Placebo

4 daily capsules of similar appearance and flavor without active ingredient

Intervention Type DRUG

Other Intervention Names

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Control

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No