Características basales y cambios en el tratamiento tras el periodo de optimización de los pacientes incluidos en el estudio EFICAR / Baseline characteristics and changes in treatment after a period of optimization of the patients included in the study EFICAR

OBJETIVO: Se describen los datos basales de clase y capacidad funcional, comorbilidades, calidad de vida y cambios en la medicación durante la optimización del tratamiento, en pacientes con insuficiencia cardiaca y función sistólica deprimida (ICFSD) incluidos en el estudio EFICAR. DISEÑO: Ensayo clínico aleatorizado multicéntrico. EMPLAZAMIENTO: Siete Centros de Salud. PARTICIPANTES: Ciento cincuenta pacientes con ICFSD; edad 68 ± 10 años, 77% varones. Mediciones: Variables sociodemográficas e índice de Charlson. Se evaluó la calidad de vida y la capacidad funcional Se realizó optimización del tratamiento. RESULTADOS: La etiología principal fue la cardiopatía isquémica (45%). Índice de Charlson global: 2,03 ± 1,05. El 31% ingresaron durante el último año por insuficiencia cardiaca. Fracción de eyección media: 37% ± 8. Clase funcional ii: 89%. Capacidad funcional con prueba de esfuerzo: 6,3 ± 1,6. Test 6 min: 446 ± 78 m. Test de la silla: 13,7 ± 4,4 s. Dinamómetro: 34,53 ± 10,12 kgf y 0,58 ± 0,16 bar. Short Form-36 Health Survey: salud física: 43,3 ± 8,4; salud mental: 50,1 ± 10,6. Minnesota Living with Heart Failure Questionnaire global: 22,8 ± 18,7. Tras optimizar el tratamiento no varió el porcentaje de pacientes ni la dosis media de fármacos analizados. CONCLUSIONES: La mayoría de los sujetos están en clase funcional ii, con capacidad funcional y calidad de vida disminuida e índice de comorbilidad elevado. Un ajuste protocolizado del tratamiento no consigue aumentar la dosis ni el número de pacientes con fármacos eficaces para la insuficiencia cardiaca con función cardiaca deprimida

OBJECTIVES: To describe the baseline date and drugs therapy changes during treatment optimization in patients with heart failure with depressed systolic function included in the EFICAR study. DESIGN: Multicenter randomized clinical trial. LOCATION: Seven Health Centers. PARTICIPANTS: 150 patients (ICFSD) age 68 ± 10 years, 77% male. MEASUREMENTS: Sociodemographic variables, comorbidities (Charlson index), functional capacity and quality of life. Drug therapy optimization was performed. RESULTS: The main etiology was ischemic heart disease (45%), with 89% in functional class ii. The Charlson index was 2.03 ± 1.05. The ejection fraction mean was 37% ± 8, 19% with ejection fraction < 30%. With the stress test 6.3 ± 1.6 mean was reached, with the 6 minutes test 446 ± 78 meters and the chair test 13.7 ± 4.4 seconds. The overall quality of life with ejection fraction was 22.8 ± 18.7 and with the Short Form-36 Health Survey, physical health 43.3 ± 8.4 and mental health 50.1 ± 10.6. After optimizing the treatment, the percentage of patients on drugs therapy and the dose of angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists and beta-blockers were not changed. CONCLUSIONS: The majority of the subjects are in functional class ii, with functional capacity and quality of life decreased and comorbidity index high. A protocolized drug therapy adjustment did not increase the dose or number of patients with effective drugs for heart failure with depressed systolic function

[Baseline characteristics and changes in treatment after a period of optimization of the patients included in the study EFICAR]. / Características basales y cambios en el tratamiento tras el periodo de optimización de los pacientes incluidos en el estudio EFICAR.

OBJECTIVES: To describe the baseline date and drugs therapy changes during treatment optimization in patients with heart failure with depressed systolic function included in the EFICAR study. DESIGN: Multicenter randomized clinical trial. LOCATION: Seven Health Centers. PARTICIPANTS: 150 patients (ICFSD) age 68±10 years, 77% male. MEASUREMENTS: Sociodemographic variables, comorbidities (Charlson index), functional capacity and quality of life. Drug therapy optimization was performed. RESULTS: The main etiology was ischemic heart disease (45%), with 89% in functional class II. The Charlson index was 2.03±1.05. The ejection fraction mean was 37%±8, 19% with ejection fraction <30%. With the stress test 6.3±1.6 mean was reached, with the 6 minutes test 446±78 meters and the chair test 13.7±4.4 seconds. The overall quality of life with ejection fraction was 22.8±18.7 and with the Short Form-36 Health Survey, physical health 43.3±8.4 and mental health 50.1±10.6. After optimizing the treatment, the percentage of patients on drugs therapy and the dose of angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists and beta-blockers were not changed. CONCLUSIONS: The majority of the subjects are in functional class II, with functional capacity and quality of life decreased and comorbidity index high. A protocolized drug therapy adjustment did not increase the dose or number of patients with effective drugs for heart failure with depressed systolic function.

Effectiveness of a smartphone application for improving healthy lifestyles, a randomized clinical trial (EVIDENT II): study protocol.

BACKGROUND: New technologies could facilitate changes in lifestyle and improve public health. However, no large randomized, controlled studies providing scientific evidence of the benefits of their use have been made. The aims of this study are to develop and validate a smartphone application, and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity. An evaluation is also made of the effect of modifying habits upon vascular structure and function, and therefore on arterial aging. METHODS/DESIGN: A randomized, double-blind, multicenter, parallel group clinical trial will be carried out. A total of 1215 subjects under 70 years of age from the EVIDENT trial will be included. Counseling common to both groups (control and intervention) will be provided on adaptation to the Mediterranean diet and on physical activity. The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity, and will use the application for three months. The main study endpoints will be the changes in physical activity, assessed by accelerometer and the 7-day Physical Activity Recall (PAR) interview, and adaptation to the Mediterranean diet, as evaluated by an adherence questionnaire and a food frequency questionnaire (FFQ). Evaluation also will be made of vascular structure and function based on central arterial pressure, the radial augmentation index, pulse velocity, the cardio-ankle vascular index, and carotid intima-media thickness. DISCUSSION: Confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications, and may contribute to generalize their application in favor of improved population health. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT02016014.