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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02708771

Acronym

PROTEICA

Enrollment

Registered

2016-03-15

Start date

2016-03-31

Completion date

2018-06-30

Last updated

2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

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

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.

Interventions

DRUGPolyunsaturated 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.

DRUGPlacebo

4 daily capsules of similar appearance and flavor without active ingredient

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Serum albumin levels	Four weeks	Serum albumin levels in the fourth week

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026