Effect of W-3 Polyunsaturated Fatty Acids on Serum Albumin Concentration in Patients With Acute Heart Failure, Hypoalbuminemia, and High Inflammatory Activity
PROTEICA
1 other identifier
interventional
42
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 heart-failure
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 6, 2016
CompletedFirst Posted
Study publicly available on registry
March 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedFebruary 10, 2021
February 1, 2021
2.3 years
March 6, 2016
February 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Serum albumin levels
Serum albumin levels in the fourth week
Four weeks
Secondary Outcomes (3)
C-reactive protein levels
Four weeks
NTproBNP levels
Four weeks
Combined event of death from any cause or readmission for heart failure
Three months
Study Arms (2)
Intervention
EXPERIMENTAL4 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.
Control
PLACEBO COMPARATORCapsules of similar appearance and flavor without active drug
Interventions
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.
4 daily capsules of similar appearance and flavor without active ingredient
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital San Juan de la Cruz
Úbeda, Jaen, 23400, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Cardiology
Study Record Dates
First Submitted
March 6, 2016
First Posted
March 15, 2016
Study Start
March 1, 2016
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
February 10, 2021
Record last verified: 2021-02