Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02708771
Recruitment Status : Unknown
Verified March 2016 by Juan Luis Bonilla Palomas, Hospital San Juan de la Cruz.
Recruitment status was:  Recruiting
First Posted : March 15, 2016
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Juan Luis Bonilla Palomas, Hospital San Juan de la Cruz

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
Heart Failure 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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 Name: Control




Primary Outcome Measures :
  1. Serum albumin levels [ Time Frame: Four weeks ]
    Serum albumin levels in the fourth week


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708771


Locations
Layout table for location information
Spain
Hospital San Juan de la Cruz Recruiting
Úbeda, Jaen, Spain, 23400
Contact: Juan Luis Bonilla Palomas       juanl.bonilla.sspa@juntadeandalucia.es   
Principal Investigator: Juan Luis Bonilla Palomas         
Sub-Investigator: Antonio Luis Gámez López         
Sponsors and Collaborators
Hospital San Juan de la Cruz

Layout table for additonal information
Responsible Party: Juan Luis Bonilla Palomas, Head of Cardiology, Hospital San Juan de la Cruz
ClinicalTrials.gov Identifier: NCT02708771     History of Changes
Other Study ID Numbers: HSJC-CAR-01-2015
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Hypoalbuminemia
Heart Diseases
Cardiovascular Diseases
Hypoproteinemia
Blood Protein Disorders
Hematologic Diseases
Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors