Trial | NCT02708771  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fish oil ...

  • Study Participants

    42
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 Started
Mar 31
2016
Primary Completion
Jun 30
2018
Study Completion
Jun 30
2018
Last Update
Feb 10
2021

Drug 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.

Drug Placebo

4 daily capsules of similar appearance and flavor without active ingredient

  • Other names: Control

Intervention Experimental

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 Placebo Comparator

Capsules of similar appearance and flavor without active drug

Criteria 

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.
No Results Posted