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CompletedNCT02708771PROTEICAUpdated Feb 10, 2021

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

A Phase 3 interventional study of Polyunsaturated fatty acids omega-3 and Placebo in Heart Failure, sponsored by Hospital San Juan de la Cruz. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-10.

Sponsored by Hospital San Juan de la Cruz · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.
02

Conditions studied

  • Heart Failure
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 42 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Hospital San Juan de la Cruz is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Polyunsaturated fatty acids omega-3

  • Placebo comparator
    Control

    Capsules of similar appearance and flavor without active drug

    Drug: Placebo

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

    Also known as: Control

06

What researchers measure

Primary outcomes

  1. Serum albumin levels

    Serum albumin levels in the fourth week

    Time frame: Four weeks

Secondary outcomes

  1. C-reactive protein levels

    C-reactive protein levels in the fourth week

    Time frame: Four weeks

  2. NTproBNP levels

    NTproBNP levels in the fourth week

    Time frame: Four weeks

  3. 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

07

Study locations

1 site
  • Hospital San Juan de la Cruz
    Úbeda, Jaen 23400, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02708771
Lead sponsor
Hospital San Juan de la Cruz
Responsible party
Juan Luis Bonilla Palomas (Head of Cardiology, Hospital San Juan de la Cruz) — Principal investigator
First posted
Mar 15, 2016
Start date
Mar 2016
Primary completion
Jun 2018
Completion
Jun 2018
Last update
Feb 10, 2021

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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