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

February 9, 2021 updated by: Juan Luis Bonilla Palomas, Hospital San Juan de la Cruz
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 Comparator: Control
Capsules of similar appearance and flavor without active drug
Drug: Placebo
4 daily capsules of similar appearance and flavor without active ingredient
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum albumin levels
Time Frame: Four weeks
Serum albumin levels in the fourth week
Four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive protein levels
Time Frame: Four weeks
C-reactive protein levels in the fourth week
Four weeks
NTproBNP levels
Time Frame: Four weeks
NTproBNP levels in the fourth week
Four weeks
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
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Juan de la Cruz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

March 6, 2016

First Submitted That Met QC Criteria

March 10, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSJC-CAR-01-2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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