Heart failure
Conditions
Interventions
Product Name: Polyunsaturated fatty acids omega-3
Pharmaceutical Form: Capsule
INN or Proposed INN: EICOSAPENTAENOIC ACID ETHYL ESTER
CAS Number: 73310-10-8
Other descriptive name: EICOSAPENTAENOIC AC
Sponsors
Juan Luis Bonilla Palomas
Eligibility
Sex/Gender
All
Inclusion 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). 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - 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.;Primary end point(s): Serum albumin levels;Timepoint(s) of evaluation of this end point: Firts and fourth weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): C-reactive protein levels NTproBNP levels 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. NTproBNP levels: first and fourth weeks. Combined event of death from any cause or readmission for heart failure within three months after randomization: 3 months | — |
Countries
Spain
Contacts
Public ContactDepartment of Cardiology
Hospital Comarcal San Juan de la Cruz
Outcome results
None listed