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

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708771
• Other study ID #: HSJC-CAR-01-2015
• Status: Completed
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: June 2018

Study information

• Verified date: February 2021
• Source: Hospital San Juan de la Cruz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Hypoalbuminemia

Intervention

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
4 daily capsules of similar appearance and flavor without active ingredient

Locations

Country	Name	City	State
Spain	Hospital San Juan de la Cruz	Úbeda	Jaen

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Juan de la Cruz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum albumin levels	Serum albumin levels in the fourth week	Four weeks
Secondary	C-reactive protein levels	C-reactive protein levels in the fourth week	Four weeks
Secondary	NTproBNP levels	NTproBNP levels in the fourth week	Four weeks
Secondary	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	Three months