E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Heart failure |
Insuficiencia cardiaca |
|
E.1.1.1 | Medical condition in easily understood language |
Heart failure |
Insuficiencia cardiaca |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Evaluar si altas dosis de ácidos grasos ?-3 añadidos al tratamiento habitual del paciente con insuficiencia cardiaca aguda que además presenta hipoalbuminemia y una actividad inflamatoria elevada, propicia un incremento de la concentración sérica de albúmina. |
|
E.2.2 | Secondary objectives of the trial |
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. |
evaluar el efecto de altas dosis de ácidos grasos ?-3 añadidos al tratamiento habitual del paciente con insuficiencia aguda que además presenta hipoalbuminemia y una actividad inflamatoria elevada sobre: - La actividad inflamatoria (Proteína C-reactiva). - La evolución de biomarcadores (NTproBNP). - El pronóstico del paciente evaluado mediante el evento combinado de muerte por cualquier causa o reingreso por insuficiencia cardiaca a los tres meses después de la aleatorización. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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). |
Pacientes mayores de 18 años hospitalizados por IC aguda, ya sea crónica descompensada o de nueva aparición, de cualquier etiología, que presenten hipoalbuminemia (albúmina sérica ?3,4 g/dl) y una actividad inflamatoria elevada (PCR ?2,5 mg/dl). |
|
E.4 | Principal 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. |
Pronóstico vital infausto Participante en otros ensayos clínicos Tratamiento con ácidos ?-3 en el último mes previo al ingreso Tratamiento percutáneo o quirúrgico de la causa de la insuficiencia cardiaca durante el ingreso. Mujeres embarazadas. Insuficiencia renal en diálisis. Insuficiencia hepática Child-Pugh B o C. Proceso infeccioso agudo. Neoplasia maligna activa. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Serum albumin levels |
Concentración sérica de albúmina |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Firts and fourth weeks |
primera y cuarta semanas |
|
E.5.2 | 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. |
Concentración de proteína C-reactiva Concentración de NTproBNP
Evento combinado de muerte por cualquier causa o reingreso por insuficiencia cardiaca a los tres meses después de la aleatorización. |
|
E.5.2.1 | 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 |
Concentración de proteína C-reactiva: primera y cuarta semanas Concentración de NTproBNP: primera y cuarta semanas.
Evento combinado de muerte por cualquier causa o reingreso por insuficiencia cardiaca a los tres meses después de la aleatorización: 3 meses |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |