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

Phase 3

Completed

• Conditions: Heart Failure
• Interventions: Drug: Polyunsaturated fatty acids omega-3; Drug: Placebo

• Registration Number: NCT02708771
• Lead Sponsor: 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

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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-06
• Study First Submitted QC: 2016-03-10
• Study First Posted: 2016-03-15
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	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.
Control	Placebo	Capsules of similar appearance and flavor without active drug

Primary Outcome Measures

Name	Time	Method
Serum albumin levels	Four weeks	Serum albumin levels in the fourth week

Secondary Outcome Measures

Name	Time	Method
NTproBNP levels	Four weeks	NTproBNP levels in the fourth week
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
C-reactive protein levels	Four weeks	C-reactive protein levels in the fourth week

Trial Locations

Locations (1)

Hospital San Juan de la Cruz; 🇪🇸 Úbeda, Jaen, Spain