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OpenTrials
Completed

NCT Number: NCT02708771

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

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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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital San Juan de la Cruz

Úbeda, Jaen, 23400, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polyunsaturated fatty acids omega-3

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.

Placebo

Drug

4 daily capsules of similar appearance and flavor without active ingredient

Other names: Control

Primary outcomes

  1. Serum albumin levels

    Time frame: Four weeks

    Serum albumin levels in the fourth week

Secondary outcomes

  1. C-reactive protein levels

    Time frame: Four weeks

    C-reactive protein levels in the fourth week

  2. NTproBNP levels

    Time frame: Four weeks

    NTproBNP levels in the fourth week

  3. Combined event of death from any cause or readmission for heart failure

    Time frame: Three months

    Combined event of death from any cause or readmission for heart failure within three months after randomization

Sponsors and collaborators

Lead sponsor

Hospital San Juan de la Cruz

Other

Registry information

Acronym: PROTEICA

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 15, 2016
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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