Effect of ?-3 polyunsaturated fatty acids on serum albumin concentration in patients with acute heart failure, hypoalbuminemia, and high inflammatory activity

Conditions: Heart failure
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2015-003048-37-ES

Lead Sponsor: Juan Luis Bonilla Palomas

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: 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:<br>- Inflammatory activity (C-reactive protein)<br>- The development of biomarkers (NTproBNP).<br>- The prognosis of patients evaluated by the combined event of death from any cause or readmission for heart failure within three months after randomization.;Primary end point(s): Serum albumin levels;Timepoint(s) of evaluation of this end point: Firts and fourth weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): C-reactive protein levels <br>NTproBNP levels<br>Combined event of death from any cause or readmission for heart failure within three months after randomization.;Timepoint(s) of evaluation of this end point: C-reactive protein levels: first and fourth weeks.<br>NTproBNP levels: first and fourth weeks.<br>Combined event of death from any cause or readmission for heart failure within three months after randomization: 3 months