E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Heart failure patients with depressed left ventricular ejection fraction |
Pacientes con insuficiencia cardiaca con fracción de eyección del ventrículo izquierdo deprimida |
|
E.1.1.1 | Medical condition in easily understood language |
Heart failure patients with diminished cardiac function |
Pacientes con insuficiencia cardiaca reducida |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019279 |
E.1.2 | Term | Heart failure |
E.1.2 | System Organ Class | 100000004849 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010684 |
E.1.2 | Term | Congestive heart failure |
E.1.2 | System Organ Class | 100000004849 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019284 |
E.1.2 | Term | Heart failure, congestive |
E.1.2 | System Organ Class | 100000004849 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024106 |
E.1.2 | Term | Left heart failure |
E.1.2 | System Organ Class | 100000004849 |
|
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 |
To assess the change in the pulmonary arterial preassure and the cardiac output with levosimendan or dobutamin |
Evaluar el cambio en la presión arterial pulmonar y el gasto cardiaco con levosimendán o dobutamina |
|
E.2.2 | Secondary objectives of the trial |
Assess the hospital admisions and mortality, the changes in quality of life, changes in cardiac biomarkers (CA125, ST2, TnT, NTproBNP), changes in pulmonary echocardiography, changes in renal function and arterial hipotension. |
-Evaluar los reingresos por IC y la mortalidad durante el período de seguimiento. - Evaluar el impacto en la calidad de vida y la capacidad funcional (6MWT). - Describir la evolución de biomarcadores (CA125, ST2, TnT, NTProBNP). - Monitorizar la evolución de la congestión pulmonar (Líneas B en la ecografía pulmonar). - Evaluar el deterioro de la función renal (reducción del 50% del filtrado glomerular o creatinina >3 mg/dl) o hipotensión arterial (tensión arterial sistólica <100 mmHg). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age> 18 years 2. FEVI <35% for echocardiography in the last 6 months 3. Functional class NYHA> III with functional impairment despite optimized treatment of HF and diuretic with admission or decompensation treated on an outpatient basis with diuretic in the last six months that motivate the implementation of the CardioMEMS device 4. Signing of informed consent |
1. Edad >18 años 2. FEVI<35% por ecocardiografía en los últimos 6 meses 3. Clase funcional NYHA>III con deterioro funcional a pesar de un tratamiento optimizado de la IC y diurético con ingreso o descompensación tratada ambulatoriamente con diurético en los últimos seis meses que motivan la implantación del dispositivo CardioMEMS 4. Firma del consentimiento informado. |
|
E.4 | Principal exclusion criteria |
1. Creatinine clearance <20 ml / min 2. Systolic blood pressure <90 mmHg 3. Pregnant or fertile women (who are in the period between menorrhagia and menopause) without effective contraceptive coverage, or in breastfeeding 4. Hypersensitivity to the active ingredients or to any of the excipients |
1. FGE <20 ml/min 2. Presión arterial sistólica <90 mmHg 3. Mujeres embarazadas o en edad fértil (que se encuentren en el período entre la menorrea y la menopausia) sin cobertura anticonceptiva eficaz, o en el período de lactancia 4. Hipersensibilidad a los principios activos o a algún excipiente |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Pulmonary blood pressure measured in mmhg and cardiac output measured in l / min |
Presión arterial pulmonar medida en mmhg y caudal cardíaco medido en l/min mediante el dispositivo CardioMEMS. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Combined criteria for death or rehospitalization for heart failure at the beginning and end of each period. - Scores observed in the EuroQoL-5D quality of life test at the beginning and end of each period. - Scores observed in the 6-minute test at the beginning and end of each period. - CA125, ST2, TnT and NTProBNP levels at the beginning and end of each period. - Pulmonary congestion parameters by pulmonary ultrasound: B lines. - Renal function parameters:% of glomerular filtrate or creatinine levels (mg / dl), hypotension (systolic blood pressure <100mmHg). - Adverse events resulting from the administration of the drug |
Criterio combinado de muerte o rehospitalización por insuficiencia cardíaca al inicio y final de cada período. - Puntuaciones observadas en el test de calidad de vida EuroQoL-5D al inicio y al final de cada período. - Puntuaciones observadas en el test de los 6 minutos al inicio y al final de cada período. - Niveles de CA125, ST2, TnT y NTProBNP al inicio y al final de cada período. - Parámetros de congestión pulmonar mediante ecografía pulmonar: líneas B. - Parámetros de función renal: % filtrado glomerular o niveles de creatinina (mg/dL), niveles de potasio sérico (mmol/L), angioedema o hipotensión arterial (tensión arterial sistólica <100mmHg) - Eventos adversos derivados de la administración del fármaco. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
E.6.5 | Efficacy | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | No |
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
|
LVLS |
Última visita del último paciente |
|
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 | |
E.8.9.1 | In the Member State concerned days | |