Gender differences in drug titration among heart failure patients with reduced ejection fraction in the ETIFIC trial.

INTRODUCTION AND OBJECTIVES: Optimal medical therapy decreases mortality and heart failure (HF) hospitalizations in HF patients with reduced left ventricular ejection fraction. Women have been underrepresented in clinical trials and not specifically evaluated. This study aimed to compare the safety and effectiveness of drug titration in women vs men. METHODS: This post hoc gender study of the ETIFIC multicenter randomized trial included hospitalized patients with new-onset HF with reduced ejection fraction and New York Heart Association II-III and no contraindications to beta-blockers. A structured 4-month titration process was implemented in HF clinics. The primary endpoint was the mean relative dose (% of target dose) of beta-blockers achieved by women vs men. Secondary endpoints included the mean relative doses of angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, and mineralocorticoid receptor antagonists, adverse events, and other clinical outcomes at 6 months. RESULTS: A total of 320 patients were included, 83 (25.93%) women and 237 (74.06%) men (76 vs 213 analyzed). The mean±standard deviation of the relative doses achieved by women vs men were as follows: beta-blockers 62.08%±30.72% vs 64.4%±32.77%, with a difference of-2.32% (95%CI,-10.58-5.94), P = .580; and mineralocorticoid receptor antagonists 79.85%±27.72% vs 67.29%±31.43%, P =.003. No other differences in drug dosage were found. Multivariate analysis showed nonsignificant differences. CV mortality was 1 (1.20%) vs 3 (1.26%), P=1, and HF hospitalizations 0 (0.00%) vs 10 (4.22%), P=.125. CONCLUSIONS: In a post hoc analysis from the HF-titration ETIFIC trial, we found nonsignificant gender differences in drug dosage, cardiovascular mortality, and HF hospitalizations. Trial registry number: NCT02546856.

No inferioridad de la titulación de enfermera de insuficiencia cardiaca en comparación con la de cardiólogo de insuficiencia cardiaca. Ensayo aleatorizado multicéntrico ETIFIC / Noninferiority of heart failure nurse titration versus heart failure cardiologist titration. ETIFIC multicenter randomized trial

Introducción y objetivos: Los bloqueadores beta, inhibidores de la enzima de conversión de la angiotensina (IECA), antagonistas de los receptores de la angiotensina II (ARA-II) y antagonistas de receptores mineralocorticoides, disminuyen mortalidad y hospitalizaciones por insuficiencia cardiaca (IC) en pacientes con IC y fracción de eyección del ventrículo izquierdo reducida. Efecto dosis-dependiente. Se recomienda titulación cuidadosa. Sin embargo, las dosis subóptimas son habituales. Se comparó eficacia y seguridad de la titulación de fármacos enfermeras de IC frente a cardiólogos de IC. Métodos: ETIFIC fue un ensayo de no inferioridad, multicéntrico (20), abierto, controlado y aleatorizado. 320 pacientes hospitalizados con IC de debut, fracción de eyección reducida y New York Heart Association II-III. Sin contraindicación para bloqueadores beta, fueron aleatorizados 1:1, estratificados en bloques de 4 pacientes/hospital, 164 a titulación de enfermeras de IC frente a 156 cardiólogos de IC (analizados 144 frente a 145). El objetivo principal fue la dosis relativa media (% de dosis objetivo) de bloqueadores beta alcanzada a 4 meses. Los objetivos secundarios fueron: la dosis relativa media de IECA, ARA-II y antagonistas de receptores mineralocorticoides, variables asociadas, eventos adversos y resultados clínicos a 6 meses. Resultados: La dosis relativa media ± desviación estándar alcanzada por enfermeras de IC frente a cardiólogos de IC: bloqueadores beta 71,09 ± 31,49% frente a 56,29 ± 31,32%, diferencia 14,8% (IC95%, 7,5-22,1); p <0,001; IECA, 72,61 ± 29,80% frente a 56,13 ± 30,37%; p <0,001; ARA-II, 44,48 ± 33,47% frente a 43,51 ± 33,69%; p=0,93 y antagonistas de receptores mineralocorticoides 71 ± 32,12% frente a 70,47 ± 29,78%; p=0,86; media ± desviación estándar de visitas 6,41 ± 2,82 frente a 2,81 ± 1,58; p <0,001; n (%) efectos adversos 34 (23,6) frente a 30 (20,7), p=0,55; y hospitalizaciones por IC a 6 meses 1 (0,69) frente a 9 (5,51), p=0,01... (AU)

Introduction and objectives: Beta-blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin-II-receptor-blockers (ARB), and mineralocorticoid-receptor antagonists decrease mortality and heart failure (HF) hospitalizations in HF patients with reduced left ventricular ejection fraction. The effect is dose-dependent. Careful titration is recommended. However, suboptimal doses are common in clinical practice. This study aimed to compare the safety and efficacy of dose titration of the aforementioned drugs by HF nurses vs HF cardiologists. Methods: ETIFIC was a multicenter (n=20) noninferiority randomized controlled open label trial. A total of 320 hospitalized patients with new-onset HF, reduced ejection fraction and New York Heart Association II-III, without beta-blocker contraindications were randomized 1:1 in blocks of 4 patients each stratified by hospital: 164 to HF nurse titration vs 156 to HF cardiologist titration (144 vs 145 analyzed). The primary endpoint was the beta-blocker mean relative dose (% of target dose) achieved at 4 months. Secondary endpoints included ACE inhibitors, ARB, and mineralocorticoid-receptor antagonists mean relative doses, associated variables, adverse events, and clinical outcomes at 6 months. Results: The mean±standard deviation relative doses achieved by HF nurses vs HF cardiologists were as follows: beta-blockers 71.09%±31.49% vs 56.29%±31.32%, with a difference of 14.8% (95%CI, 7.5-22.1), P <.001; ACE inhibitors 72.61%±29.80% vs 56.13%±30.37%, P <.001; ARB 44.48%±33.47% vs 43.51%±33.69%, P=.93; and mineralocorticoid-receptor antagonists 71%±32.12% vs 70.47%±29.78%, P=.86; mean±standard deviation visits were 6.41±2.82 vs 2.81±1.58, P <.001, while the number (%) of adverse events were 34 (23.6) vs 30 (20.7), P=.55; and at 6 months HF hospitalizations were 1 (0.69) vs 9 (5.51), P=.01... (AU)

Noninferiority of heart failure nurse titration versus heart failure cardiologist titration. ETIFIC multicenter randomized trial.

INTRODUCTION AND OBJECTIVES: Beta-blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin-II-receptor-blockers (ARB), and mineralocorticoid-receptor antagonists decrease mortality and heart failure (HF) hospitalizations in HF patients with reduced left ventricular ejection fraction. The effect is dose-dependent. Careful titration is recommended. However, suboptimal doses are common in clinical practice. This study aimed to compare the safety and efficacy of dose titration of the aforementioned drugs by HF nurses vs HF cardiologists. METHODS: ETIFIC was a multicenter (n=20) noninferiority randomized controlled open label trial. A total of 320 hospitalized patients with new-onset HF, reduced ejection fraction and New York Heart Association II-III, without beta-blocker contraindications were randomized 1:1 in blocks of 4 patients each stratified by hospital: 164 to HF nurse titration vs 156 to HF cardiologist titration (144 vs 145 analyzed). The primary endpoint was the beta-blocker mean relative dose (% of target dose) achieved at 4 months. Secondary endpoints included ACE inhibitors, ARB, and mineralocorticoid-receptor antagonists mean relative doses, associated variables, adverse events, and clinical outcomes at 6 months. RESULTS: The mean±standard deviation relative doses achieved by HF nurses vs HF cardiologists were as follows: beta-blockers 71.09%±31.49% vs 56.29%±31.32%, with a difference of 14.8% (95%CI, 7.5-22.1), P <.001; ACE inhibitors 72.61%±29.80% vs 56.13%±30.37%, P <.001; ARB 44.48%±33.47% vs 43.51%±33.69%, P=.93; and mineralocorticoid-receptor antagonists 71%±32.12% vs 70.47%±29.78%, P=.86; mean±standard deviation visits were 6.41±2.82 vs 2.81±1.58, P <.001, while the number (%) of adverse events were 34 (23.6) vs 30 (20.7), P=.55; and at 6 months HF hospitalizations were 1 (0.69) vs 9 (5.51), P=.01. CONCLUSIONS: ETIFIC is the first multicenter randomized trial to demonstrate the noninferiority of HF specialist-nurse titration vs HF cardiologist titration. Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations. Trial registry number: NCT02546856.

Design of a multicentre randomized controlled trial to assess the safety and efficacy of dose titration by specialized nurses in patients with heart failure. ETIFIC study protocol.

AIMS: Heart failure (HF) is associated with many hospital admissions and relatively high mortality, rates decreasing with administration of beta-blockers (BBs), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blockers, and mineralocorticoid receptor antagonists. The effect is dose dependent, suboptimal doses being common in clinical practice. The 2012 European guidelines recommend close monitoring and dose titration by HF nurses. Our main aim is to compare BB doses achieved by patients after 4 months in intervention (HF nurse-managed) and control (cardiologist-managed) groups. Secondary aims include comparing doses of the other aforementioned drugs achieved after 4 months, adverse events, and outcomes at 6 months in the two groups. METHODS: We have designed a multicentre (20 hospitals) non-inferiority randomized controlled trial, including patients with new-onset HF, left ventricular ejection fraction ≤40%, and New York Heart Association class II-III, with no contraindications to BBs. We will also conduct qualitative analysis to explore potential barriers to and facilitators of dose titration by HF nurses. In the intervention group, HF nurses will implement titration as prescribed by cardiologists, following a protocol. In controls, cardiologists will both prescribe and titrate doses. The study variables are doses of each of the drugs after 4 months relative to the target dose (%), New York Heart Association class, left ventricular ejection fraction, N-terminal pro B-type natriuretic peptide levels, 6 min walk distance, comorbidities, renal function, readmissions, mortality, quality of life, and psychosocial characteristics. CONCLUSIONS: The trial seeks to assess whether titration by HF nurses of drugs recommended in practice guidelines is safe and not inferior to direct management by cardiologists. The results could have an impact on clinical practice.

Seguimiento del paciente con insuficiencia cardíaca: coordinación e integración entre niveles asistenciales / Monitoring the patient with heart failure: coordination and integration between healthcare levels

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El paciente con insuficiencia cardiaca aguda: caso clínico / The heart failure patient: A case report

La insuficiencia cardiaca (IC) por su prevalencia, cronicidad, morbimortalidad y consumo de recursos constituye un problema prioritario desde el punto de vista socio sanitario, debido al envejecimiento de la población, a la falta de adherencia y la complejidad en los tratamientos. Debido a la magnitud del problema está justificado establecer un plan de cuidados individualizado para resolver las necesidades de salud reales y potenciales en un paciente diagnosticado de IC. El caso se desarrolla en un hospital de tercer nivel, en una Unidad de Cuidados Críticos Cardiológicos (UCC).Para ello, elaboramos el plan de cuidados del paciente siguiendo los pasos del método científico y apoyándonos en la taxonomía NANDA, así como en la NOC y NIC para delimitar objetivos e intervenciones enfermeras, respectivamente

Given its prevalence, high mortality rate, morbidity, chronicity and use of resources, heart failure (HF) is a priority issue from a social and health standpoint, due to the ageing population and to lack of adherence to and the complexity of treatment. For these reasons, an individualized care plan needs to be established to meet the real and potential needs of the patient diagnosed with HF.A clinical case is presented of a patient admitted to the Cardiology Critical Care (CCC) unit of a tertiary hospital. A patient care plan was prepared following the steps of the scientific method and relying on the NANDA taxonomy, and the NOC and NIC to design goals and nursing interventions, respectively

[The heart failure patient: a case report]. / El paciente con insuficiencia cardiaca aguda: caso clínico.

Given its prevalence, high mortality rate, morbidity, chronicity and use of resources, heart failure (HF) is a priority issue from a social and health standpoint, due to the ageing population and to lack of adherence to and the complexity of treatment. For these reasons, an individualized care plan needs to be established to meet the real and potential needs of the patient diagnosed with HF. A clinical case is presented of a patient admitted to the Cardiology Critical Care (CCC) unit of a tertiary hospital. A patient care plan was prepared following the steps of the scientific method and relying on the NANDA taxonomy, and the NOC and NIC to design goals and nursing interventions, respectively.

Valoración del registro de la información del plan de cuidados y de la trayectoria clínica de la implantación del catéter peritoneal / Evaluation of the recording of information on the care plan and clinical path in the implementation of a peritoneal catheter

El objetivo de este estudio es elaborar y valorar la implantación del plan de cuidados y la trayectoria clínica de la colocación del catéter peritoneal para corroborar que la trayectoria clínica es un buen registro para enfermería. Para elaborar el plan de cuidados hemos realizado la valoración según las necesidades de V. Henderson. Para la formulación de los diagnósticos hemos utilizado la TaxonomiaII de la NANDA y para las intervenciones y los resultados hemos relacionado el NIC y el NOC. La trayectoria clínica resalta el proceso por el cual pasa el enfermo desde la implantación del catéter (2 días de hospitalización), el control ambulatorio en la unidad de diálisis peritoneal cada 24 horas (8 días), hasta el inicio definitivo del tratamiento. Se ha diseñado una hoja para registrar las incidencias de la trayectoria clínica que nos permita detectar las desviaciones para poder utilizar las medidas correctoras. La trayectoria clínica cumple las mismas características que los registros. Estos instrumentos de gestión han facilitado la calidad de los cuidados, teniendo en cuenta acciones centradas en los resultados y permiten conocer la estimación de los costs generados por la enfermería

The aim of this study is to draw up and evaluate the implementation of the care plan and the clinical path in the placing of a peritoneal catheter to check that the clinical path is a good record for nursing. To draw up the care plan, we have conducted the evaluation on the basis of the needs of V. Henderson. For diagnoses we have used NANDA Taxonomy II and for interventions and outcomes we have related NIC and NOC. The clinical path highlights the process undergone by the patient from implementation of the catheter (2 days in hospital), control in the peritoneal dialysis unit every 24 hours (8days) until treatment definitively commences. A sheet has been designed to record incidences in the clinical path that lets us detect any deviations in order to apply corrective measures. The clinical path has the same characteristics as the records. These management instruments have facilitated the quality of care, taking into account outcome-focused actions and make it possible to estimate the costs generated by nursing