Effect of W-3 Polyunsaturated Fatty Acids on Serum Albumin Concentration in Patients With Acute Heart Failure, Hypoalbuminemia, and High Inflammatory Activity (PROTEICA)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Polyunsaturated fatty acids omega-3
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility 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.
Sites / Locations
- Hospital San Juan de la Cruz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
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.
Capsules of similar appearance and flavor without active drug
Outcomes
Primary Outcome Measures
Serum albumin levels
Serum albumin levels in the fourth week
Secondary Outcome Measures
C-reactive protein levels
C-reactive protein levels in the fourth week
NTproBNP levels
NTproBNP levels in the fourth week
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
Full Information
NCT ID
NCT02708771
First Posted
March 6, 2016
Last Updated
February 9, 2021
Sponsor
Hospital San Juan de la Cruz
1. Study Identification
Unique Protocol Identification Number
NCT02708771
Brief Title
Effect of W-3 Polyunsaturated Fatty Acids on Serum Albumin Concentration in Patients With Acute Heart Failure, Hypoalbuminemia, and High Inflammatory Activity
Acronym
PROTEICA
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 Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Juan de la Cruz
4. Oversight
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Capsules of similar appearance and flavor without active drug
Intervention Type
Drug
Intervention Name(s)
Polyunsaturated fatty acids omega-3
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control
Intervention Description
4 daily capsules of similar appearance and flavor without active ingredient
Primary Outcome Measure Information:
Title
Serum albumin levels
Description
Serum albumin levels in the fourth week
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
C-reactive protein levels
Description
C-reactive protein levels in the fourth week
Time Frame
Four weeks
Title
NTproBNP levels
Description
NTproBNP levels in the fourth week
Time Frame
Four weeks
Title
Combined event of death from any cause or readmission for heart failure
Description
Combined event of death from any cause or readmission for heart failure within three months after randomization
Time Frame
Three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital San Juan de la Cruz
City
Úbeda
State/Province
Jaen
ZIP/Postal Code
23400
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Effect of W-3 Polyunsaturated Fatty Acids on Serum Albumin Concentration in Patients With Acute Heart Failure, Hypoalbuminemia, and High Inflammatory Activity
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