E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Heart failure with preserved or moderately reduced eyection fraction |
Insuficiencia cardíaca con fracción de eyección preservada o moderadamente deprimida. |
|
E.1.1.1 | Medical condition in easily understood language |
Heart failure with preserved or moderately reduced eyection fraction |
Insuficiencia cardíaca con fracción de eyección preservada o moderadamente deprimida. |
|
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 |
To evaluate the efficacy of Vitamin D supplementation in patients with heart failure with preserved or moderately reduced ejection fraction who have Vitamin D deficiency on the longitudinal and circumferential ventricular deformation rate (STRAIN). |
Evaluar la eficacia de la suplementación con Vitamina D en pacientes con insuficiencia cardíaca con fracción de eyección preservada o moderadamente reducida que presenten déficit de Vitamina D sobre la tasa de deformación ventricular longitudinal y circunferencial del ventrículo izquierdo. |
|
E.2.2 | Secondary objectives of the trial |
- Assess differences in mortality between the treatment arm (vitamin D) and the placebo arm of the study. - Assess differences in the re-admission rate and time to first admission between the treatment arm (Vitamin D) and the placebo arm of the study. - Assess differences in the quality of life of patients between the treatment arm (vitamin D) and the placebo arm of the study. - Assess differences in baseline dyspnea of patients according to the NYHA classification between the treatment arm (vitamin D) and the placebo arm of the study. |
- Valorar diferencias en la mortalidad entre el brazo de tratamiento (vitamina D) y el brazo placebo del estudio. - Valorar diferencias en la tasa de reingreso y en el tiempo hasta el primer ingreso entre el brazo de tratamiento (Vitamina D) y el brazo placebo del estudio. - Valorar diferencias en la calidad de vida de los pacientes entre el brazo de tratamiento (vitamina D) y el brazo placebo del estudio. - Valorar diferencias en la disnea basal de los pacientes según la clasificación NYHA entre el brazo de tratamiento (vitamina D) y el brazo placebo del estudio. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A.- Heart failure with preserved or moderately reduced ejection fraction (HFp / HFmr) that meet diagnostic criteria according to the Clinical Guidelines of the European Society of Cardiology : - At least one episode of symptoms and / or signs of heart failure in the last 6 months. - Demonstrated ejection fraction> 40% (including clinical entities of preserved and moderately reduced ejection fraction). - Elevation natriuretic peptides: NTproBNP> 125 pg / ml or BNP> 35 pg / ml - Demonstration of structural heart disease: Left ventricular hypertrophy / left atrial enlargement / diastolic dysfunction B.- Vitamin D deficiency demonstrated with serum levels <20 ng / mL (vitamin deficit). |
A.- Insuficiencia cardíaca con fracción de eyección preservada o moderadamente reducida (ICFEp/ICFEmr) que cumplan criterios diagnósticos según las Guías Clínicas de la Sociedad Europea de Cardiología (11): - Al menos un episodio de síntomas y/o signos de insuficiencia cardíaca en los últimos 6 meses. - Fracción de eyección demostrada > 40% (incluyendo las entidades clínica de fracción de eyección preservada y moderadamente reducida). - Elevación péptidos natriuréticos: o NTproBNP > 125 pg/ml ó o BNP > 35 pg/ml - Demostración de enfermedad estructural del corazón: o Hipertrofia de ventrículo izquierdo / aumento de aurícula izquierda o Y/o disfunción diastólica B.- Déficit de Vitamina D demostrado con niveles séricos <20 ng/mL (déficit vitamínico). |
|
E.4 | Principal exclusion criteria |
- Active treatment with Vitamin D supplements. - Advanced chronic kidney disease with glomerular filtration <30 ml / min / 1.73m2. - Malabsorptive syndromes that interfere with the absorption of vitamin D. - Diseases that affect the metabolism of calcium and phosphorus. - Hypercalcemia (serum calcium corrected with albumin> 10.5 mg / dL). - Severe valvular disease of any origin. - Atrial fibrillation. - Severe psychosocial problems (dementia, alcoholism, any consumption of toxics, psychiatric disorders or moderate or severe cognitive impairment of any origin that prevent the patient's follow-up or adherence to the study). |
- Tratamiento activo con suplementos de Vitamina D. - Enfermedad renal crónica avanzada con filtrado glomerular < 30 ml/min/1.73m2. - Síndromes malabsortivos que interfieran con la absorción de vitamina D. - Enfermedades que afecten al metabolismo del calcio y el fósforo. - Hipercalcemia (calcio sérico corregido con albúmina > 10.5 mg/dL). - Valvulopatías severas de cualquier origen. - Fibrilación auricular. - Problemas psicosociales severos (demencia, alcoholismo, cualquier consumo de tóxicos, trastornos psiquiátricos o deterioro cognitivo moderado o severo de cualquier origen que impidan el seguimiento del paciente o su adherencia al estudio). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Absolute change from baseline in the longitudinal deformation of the left ventricle. |
Cambios en la deformación ventricular del ventrículo izquierdo sobre el valor basal. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Time to first admission. |
Tiempo hasta el primer ingreso. |
|
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 | 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) | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | 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
|
The end for the trial for each subject participating will be the completion of 6 months of treatment with vitamin D/placebo. At the end of the trial every subject will be treated with vitamin D suplementation. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |