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

Sponsor
Hospital San Juan de la Cruz (Other)
Overall Status
Completed
CT.gov ID
NCT02708771
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
27
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Polyunsaturated fatty acids omega-3
  • Drug: Placebo
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of W-3 Polyunsaturated Fatty Acids on Serum Albumin Concentration in Patients With Acute Heart Failure, Hypoalbuminemia, and High Inflammatory Activity
Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum albumin levels [Four weeks]

      Serum albumin levels in the fourth week

    Secondary Outcome Measures

    1. C-reactive protein levels [Four weeks]

      C-reactive protein levels in the fourth week

    2. NTproBNP levels [Four weeks]

      NTproBNP levels in the fourth week

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital San Juan de la Cruz Úbeda Jaen Spain 23400

    Sponsors and Collaborators

    • Hospital San Juan de la Cruz

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Juan Luis Bonilla Palomas, Head of Cardiology, Hospital San Juan de la Cruz
    ClinicalTrials.gov Identifier:
    NCT02708771
    Other Study ID Numbers:
    • HSJC-CAR-01-2015
    First Posted:
    Mar 15, 2016
    Last Update Posted:
    Feb 10, 2021
    Last Verified:
    Feb 1, 2021
    Additional relevant MeSH terms:
    Heart Failure
    Hypoalbuminemia

    Study Results

    No Results Posted as of Feb 10, 2021