The RICA-2 registry: design and baseline characteristics of the first 1,000 patients.

BACKGROUND AND OBJECTIVE: Heart failure (HF) is a syndrome of epidemic proportions and one of the main reasons for hospital admission. Patient registries provide real-world clinical practice information which is complementary to clinical trials. RICA-2 is a registry of the Spanish Society of Internal Medicine. Its main goal is to know the clinical and epidemiological characteristics and prognostic factors of patients with HF treated in Internal Medicine Departments. The objective of this study is to present the design of the RICA-2, the baseline characteristics of the first 1000 patients included and their comparison with those of the historical cohort of the RICA registry. METHODS: Observational, multicentre and prospective study of patients with HF with the following inclusion criteria: age equal to or greater than 18 years old, diagnosis of HF according to the European Guidelines, indistinct inclusion in decompensation or stable phase, of patients with de novo HF or chronic HF, regardless of left ventricular ejection fraction, aetiology and comorbidities. RESULTS: RICA-2 patients have advanced age (83 years old) and 51% are women. The comorbidity burden is higher than in the RICA registry (5 points in the Charlson comorbidity index), with predominating chronic decompensated HF (74%), hypertensive aetiology (39%) and preserved ejection fraction (52%). Most patients are pre-frail or vulnerable and are at risk of malnutrition. CONCLUSION: The RICA-2 represents a contemporary cohort of patients that will provide us with clinical, epidemiological and prognostic information on patients with acute and chronic HF treated in Internal Medicine.

Diferencias en función del sexo en las características clínicas y resultados del ensayo clínico CLOROTIC (combinación de diuréticos de asa con tiazidas en la insuficiencia cardiaca descompensada) / Sex differences in clinical characteristics and outcomes in the CLOROTIC (combining loop with thiazide diuretics for decompensated heart failure) trial

ObjetivoEvaluar si existen diferencias en los resultados del ensayo clínico CLOROTIC según el sexo. Métodos Subanálisis del ensayo CLOROTIC, que evaluó la eficacia y la seguridad de añadir hidroclorotiazida (HCTZ) o placebo a furosemida intravenosa en pacientes con insuficiencia cardiaca aguda (ICA). Los resultados primarios y secundarios incluyeron cambios en el peso y la disnea a las 72 y 96horas, medidas de la respuesta diurética y la mortalidad y reingresos a los 30 y 90días. Se evaluó la influencia del sexo en los resultados primarios y secundarios y de seguridad. Resultados De los 230 pacientes incluidos, 111 (48%) eran mujeres, que tenían más edad y valores más elevados de fracción de eyección ventricular izquierda. Los hombres tenían más cardiopatía isquémica, enfermedad pulmonar obstructiva crónica y mayor valor de péptidos natriuréticos. La adición de HCTZ a furosemida se asoció con una mayor pérdida de peso a las 72/96horas y mejor respuesta diurética a las 24horas en comparación con el placebo, sin diferencias significativas según el sexo (ningún valor de p para la interacción fue significativo). El deterioro de la función renal fue más frecuente en mujeres (OR: 8,68; IC95%: 3,41-24,63) que en varones (OR: 2,5; IC95%: 0,99-4,87), p=0,027. No hubo diferencias en la mortalidad ni en los reingresos a los 30/90días. Conclusión La adición de HCTZ a furosemida intravenosa es una estrategia eficaz para mejorar la respuesta diurética en la ICA sin diferencias según el sexo. Sin embargo, el deterioro de la función renal es más frecuente en las mujeres. (AU)

Aims The addition of hydrochlorothiazide (HCTZ) to furosemide improved the diuretic response in patients with acute heart failure (AHF) in the CLOROTIC trial. Our aim was to evaluate if there were differences in clinical characteristics and outcomes according to sex. Methods This is a post hoc analysis of the CLOROTIC trial, including 230 patients with AHF randomized to receive HCTZ or placebo in addition to an intravenous furosemide regimen. The primary and secondary outcomes included changes in weight and patient-reported dyspnoea 72 and 96h after randomization, metrics of diuretic response and mortality/rehospitalizations at 30 and 90days. The influence of sex on primary, secondary and safety outcomes was evaluated. Results One hundred and eleven (48%) women were included in the study. Women were older and had higher values of left ventricular ejection fraction. Men had more ischemic cardiomyopathy and chronic obstructive pulmonary disease and higher values of natriuretic peptides. The addition of HCTZ to furosemide was associated to a greatest weight loss at 72/96h, better metrics of diuretic response and higher 24-h diuresis compared to placebo without significant differences according to sex (all P-values for interaction were not significant). Worsening renal function occurred more frequently in women (OR: 8.68; 95%CI: 3.41-24.63) than men (OR: 2.5; 95%CI: 0.99-4.87), P=.027. There were no differences in mortality or rehospitalizations at 30/90days. Conclusion Adding HCTZ to intravenous furosemide is an effective strategy to improve diuretic response in AHF with no difference according to sex, but worsening renal function was more frequent in women. (AU)

Diferencias en función del sexo en las características clínicas y resultados del ensayo clínico CLOROTIC (combinación de diuréticos de asa con tiazidas en la insuficiencia cardiaca descompensada) / Sex differences in clinical characteristics and outcomes in the CLOROTIC (combining loop with thiazide diuretics for decompensated heart failure) trial

ObjetivoEvaluar si existen diferencias en los resultados del ensayo clínico CLOROTIC según el sexo. Métodos Subanálisis del ensayo CLOROTIC, que evaluó la eficacia y la seguridad de añadir hidroclorotiazida (HCTZ) o placebo a furosemida intravenosa en pacientes con insuficiencia cardiaca aguda (ICA). Los resultados primarios y secundarios incluyeron cambios en el peso y la disnea a las 72 y 96horas, medidas de la respuesta diurética y la mortalidad y reingresos a los 30 y 90días. Se evaluó la influencia del sexo en los resultados primarios y secundarios y de seguridad. Resultados De los 230 pacientes incluidos, 111 (48%) eran mujeres, que tenían más edad y valores más elevados de fracción de eyección ventricular izquierda. Los hombres tenían más cardiopatía isquémica, enfermedad pulmonar obstructiva crónica y mayor valor de péptidos natriuréticos. La adición de HCTZ a furosemida se asoció con una mayor pérdida de peso a las 72/96horas y mejor respuesta diurética a las 24horas en comparación con el placebo, sin diferencias significativas según el sexo (ningún valor de p para la interacción fue significativo). El deterioro de la función renal fue más frecuente en mujeres (OR: 8,68; IC95%: 3,41-24,63) que en varones (OR: 2,5; IC95%: 0,99-4,87), p=0,027. No hubo diferencias en la mortalidad ni en los reingresos a los 30/90días. Conclusión La adición de HCTZ a furosemida intravenosa es una estrategia eficaz para mejorar la respuesta diurética en la ICA sin diferencias según el sexo. Sin embargo, el deterioro de la función renal es más frecuente en las mujeres. (AU)

Aims The addition of hydrochlorothiazide (HCTZ) to furosemide improved the diuretic response in patients with acute heart failure (AHF) in the CLOROTIC trial. Our aim was to evaluate if there were differences in clinical characteristics and outcomes according to sex. Methods This is a post hoc analysis of the CLOROTIC trial, including 230 patients with AHF randomized to receive HCTZ or placebo in addition to an intravenous furosemide regimen. The primary and secondary outcomes included changes in weight and patient-reported dyspnoea 72 and 96h after randomization, metrics of diuretic response and mortality/rehospitalizations at 30 and 90days. The influence of sex on primary, secondary and safety outcomes was evaluated. Results One hundred and eleven (48%) women were included in the study. Women were older and had higher values of left ventricular ejection fraction. Men had more ischemic cardiomyopathy and chronic obstructive pulmonary disease and higher values of natriuretic peptides. The addition of HCTZ to furosemide was associated to a greatest weight loss at 72/96h, better metrics of diuretic response and higher 24-h diuresis compared to placebo without significant differences according to sex (all P-values for interaction were not significant). Worsening renal function occurred more frequently in women (OR: 8.68; 95%CI: 3.41-24.63) than men (OR: 2.5; 95%CI: 0.99-4.87), P=.027. There were no differences in mortality or rehospitalizations at 30/90days. Conclusion Adding HCTZ to intravenous furosemide is an effective strategy to improve diuretic response in AHF with no difference according to sex, but worsening renal function was more frequent in women. (AU)

Sex differences in clinical characteristics and outcomes in the CLOROTIC (combining loop with thiazide diuretics for decompensated heart failure) trial.

AIMS: The addition of hydrochlorothiazide (HCTZ) to furosemide improved the diuretic response in patients with acute heart failure (AHF) in the CLOROTIC trial. Our aim was to evaluate if there were differences in clinical characteristics and outcomes according to sex. METHODS: This is a post-hoc analysis of the CLOROTIC trial, including 230 patients with AHF randomized to receive HCTZ or placebo in addition to an intravenous furosemide regimen. The primary and secondary outcomes included changes in weight and patient-reported dyspnoea 72 and 96 h after randomization, metrics of diuretic response and mortality/rehospitalizations at 30 and 90 days. The influence of sex on primary, secondary and safety outcomes was evaluated. RESULTS: One hundred and eleven (48%) women were included in the study. Women were older and had higher values of left ventricular ejection fraction. Men had more ischemic cardiomyopathy and chronic obstructive pulmonary disease and higher values of natriuretic peptides. The addition of HCTZ to furosemide was associated to a greatest weight loss at 72/96 h, better metrics of diuretic response and higher 24-h diuresis compared to placebo without significant differences according to sex (all p-values for interaction were not significant). Worsening renal function occurred more frequently in women (OR [95%CI]: 8.68 [3.41-24.63]) than men (OR [95%CI]: 2.5 [0.99-4.87]), p = 0.027. There were no differences in mortality or rehospitalizations at 30/90 days. CONCLUSION: Adding HCTZ to intravenous furosemide is an effective strategy to improve diuretic response in AHF with no difference according to sex, but worsening renal function was more frequent in women. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov: NCT01647932; EudraCT Number: 2013-001852-36.

Impacto pronóstico de metformina en pacientes con diabetes mellitus tipo 2 e insuficiencia cardiaca aguda. Análisis combinado de los registros EAHFE y RICA / Prognostic impact of metformin in patients with type 2 diabetes mellitus and acute heart failure: Combined analysis of the EAHFE and RICA registries

Introducción Los pacientes con diabetes mellitus (DM) e insuficiencia cardiaca (IC) presentan peor pronóstico a pesar de los avances terapéuticos en ambas enfermedades. Los inhibidores del cotransportador sodio-glucosa tipo 2 y agonistas del receptor de GLP-1 han demostrado beneficios cardiovasculares y se han posicionado como primer escalón en el tratamiento de DM en pacientes con IC o elevado riesgo cardiovascular. Sin embargo, en los ensayos pivotales la mayoría de los pacientes recibe tratamiento concomitante con metformina. Todavía no se han desarrollado ensayos clínicos aleatorizados para evaluar el impacto pronóstico de la metformina a nivel cardiovascular. Nuestro objetivo fue analizar si los pacientes con DM e IC aguda que recibían tratamiento con metformina en el momento del alta podrían presentar mejor pronóstico al año de seguimiento. Métodos Ensayo de cohortes prospectivo mediante el análisis combinado de los 2 principales registros españoles de IC: el Registro Epidemiology of Acute Heart Failure in Emergency Departments –EAHFE– y el Registro Nacional de Pacientes con Insuficiencia Cardiaca –RICA–. Resultados De un total de 4.403 pacientes con DM tipo 2, recibió tratamiento con metformina el 33% (1.453). Este grupo presentó una mortalidad significativamente inferior al año de tratamiento (22 versus 32%; test de Log Rank p<0,001). En el análisis ajustado de mortalidad, los pacientes que recibieron tratamiento con metformina presentaron menor mortalidad al año de seguimiento independientemente del resto de las variables (RR 0,814; IC 95% 0,712-0,930; p<0,01). Conclusiones Los pacientes con DM tipo 2 e IC aguda que recibieron metformina presentaron mejor pronóstico al año de seguimiento, por lo que consideramos que este fármaco debe continuar siendo un pilar fundamental en el tratamiento de estos pacientes (AU)

Introduction Patients with diabetes mellitus (DM) and heart failure (HF) have a worse prognosis despite therapeutic advances in both diseases. Sodium-glucose co-transporter type 2 and GLP-1 receptor agonists have shown cardiovascular benefits and have been positioned as the first step in the treatment of DM in patients with HF or high cardiovascular risk. However, in the pivotal trials the majority of patients receives concomitant treatment with metformin. Randomized clinical trials have not yet been developed to assess the prognostic impact of metformin at the cardiovascular level. Our objective was to analyze whether patients with DM and acute HF who receive treatment with metformin at the time of discharge may have had a better prognosis at one year of follow-up. Methods Prospective cohort trial using the combined analysis of the 2 main Spanish HF registries: the Epidemiology of Acute Heart Failure in Emergency Departments registry –EAHFE– and the National Registry of Patients with Heart Failure –RICA–. Results 33% (1453) of a total of 4403 patients with DM type 2 received treatment with metformin. This group presented significantly lower mortality after one year of treatment (22 vs. 32%; Log Rank test, p<0.001). In the adjusted analysis of mortality, patients receiving treatment with metformin had lower mortality at one year of follow-up regardless of the rest of the variables (RR 0.814; 95% CI: 0.712–0.930; p<0.01). Conclusions Patients with DM type 2 and acute HF who received metformin had a better prognosis after one year of follow-up, so we believe that this drug should continue to be a fundamental pillar in the treatment of these patients (AU)

Prognostic impact of metformin in patients with type 2 diabetes mellitus and acute heart failure: Combined analysis of the EAHFE and RICA registries.

INTRODUCTION: Patients with diabetes mellitus (DM) and heart failure (HF) have a worse prognosis despite therapeutic advances in both diseases. Sodium-glucose co-transporter type 2 and GLP-1 receptor agonists have shown cardiovascular benefits and they have been positioned as the first step in the treatment of DM in patients with HF or high cardiovascular risk. However, in the pivotal trials the majority of patients receive concomitant treatment with metformin. Randomized clinical trials have not yet been developed to assess the prognostic impact of metformin at the cardiovascular level. Our objective has been centered in analyzing whether patients with DM and acute HF who receive treatment with metformin at the time of discharge may have a better prognosis at one year of follow-up. METHODS: Prospective cohort trial using the combined analysis of the two main Spanish HF registries, the EAHFE Registry (Epidemiology of Acute Heart Failure in Emergency Departments) and the RICA (National Registry of Patients with Heart Failure). RESULTS: 33% (1453) of a total of 4403 patients with DM type 2 received treatment with metformin. This group presents significantly lower mortality after one year of treatment (22 versus 32%; Log Rank test P < 0.001). In the adjusted analysis of mortality, patients receiving treatment with metformin have lower mortality at one year of follow-up regardless of the rest of the variables (RR 0,814; 95%IC 0,712-0,930; P < 0.01). CONCLUSIONS: Patients with DM type 2 and acute HF who receive metformin have a better prognosis after one year of follow-up, so we believe that this drug should continue to be a fundamental pillar in the treatment of these patients.

Prevalencia e impacto en el pronóstico del bloqueo de rama derecha en pacientes con insuficiencia cardíaca aguda: hallazgos del registro RICA / Prevalence and impact on prognosis of right-bundle branch block in patients with acute heart failure: Findings from the RICA registry

Objetivos: Determinar la prevalencia, las características y el impacto en el pronóstico del bloqueo de rama derecha (BRD) en una cohorte de pacientes con insuficiencia cardíaca aguda (ICA). Métodos: Analizamos prospectivamente 3.638 pacientes con ICA incluidos en el Registro Nacional de Insuficiencia Cardíaca de la Sociedad Española de Medicina Interna (RICA). Analizamos de forma independiente la relación entre las características basales y clínicas y la presencia de BRD, y el impacto potencial del BRD en la mortalidad por todas las causas a un año y el evento combinado de hospitalización o muerte a 90 días después del alta. Resultados: La prevalencia de BRD fue del 10,9%. Los pacientes con BRD eran de edad más avanzada, con mayor proporción de sexo masculino y comorbilidades pulmonares, valores más altos de fracción de eyección del ventrículo izquierdo y peor estado funcional. No hubo diferencias en riesgo para los pacientes con BRD, con un cociente de riesgo ajustado (intervalo de confianza del 95%) para la mortalidad a un año de 1,05 (0,83-1,32) y para el evento combinado a 90 días después del alta de 0,97 (0,74-1,25). Estos resultados fueron consistentes en los análisis de sensibilidad. Conclusiones: Pocos pacientes con ICA presentan BRD, que se asocia consistentemente con la edad avanzada, el sexo masculino, las comorbilidades pulmonares, la fracción de eyección del ventrículo izquierdo preservada y el peor estado funcional. Sin embargo, después de tener en cuenta estos factores, el BRD en pacientes con ICA no se asocia a peores resultados (AU)

Objectives: This work aims to determine the prevalence, characteristics, and impact on prognosis of right bundle branch block (RBBB) in a cohort of acute heart failure (AHF) patients. Methods: We prospectively analyzed 3,638 AHF patients included in the RICA registry (National Heart Failure Registry of the Spanish Internal Medicine Society). We independently analyzed the relationship between baseline and clinical characteristics and the presence of RBBB as well as the potential impact of RBBB on 1-year all-cause mortality and a composite endpoint of 90-day post-discharge hospitalization or death. Results: The prevalence of RBBB was 10.9%. Patients with RBBB were older, a higher proportion were male, had more pulmonary comorbidities, had higher left ventricular ejection fraction values, and had worse functional status. There were no differences in risk for patients with RBBB, with an adjusted hazard ratio (95% confidence interval) for 1-year mortality of 1.05 (0.83-1.32), and for the composite endpoint of 90-day post-discharge hospitalization or death of 0.97 (0.74-1.25). These results were consistent on the sensitivity analyses. Conclusions: Few patients with AHF present with RBBB, which is consistently associated with advanced age, male sex, pulmonary comorbidities, preserved left ventricular ejection fraction, and worse functional status. Nonetheless, after considering these factors, RBBB in AHF patients is not associated with worse outcomes (AU)

Prevalence and impact on prognosis of right-bundle branch block in patients with acute heart failure: Findings from the RICA registry.

OBJECTIVES: This work aims to determine the prevalence, characteristics, and impact on prognosis of right bundle branch block (RBBB) in a cohort of acute heart failure (AHF) patients. METHODS: We prospectively analyzed 3,638 AHF patients included in the RICA registry (National Heart Failure Registry of the Spanish Internal Medicine Society). We independently analyzed the relationship between baseline and clinical characteristics and the presence of RBBB as well as the potential impact of RBBB on 1-year all-cause mortality and a composite endpoint of 90-day post-discharge hospitalization or death. RESULTS: The prevalence of RBBB was 10.9%. Patients with RBBB were older, a higher proportion were male, had more pulmonary comorbidities, had higher left ventricular ejection fraction values, and had worse functional status. There were no differences in risk for patients with RBBB, with an adjusted hazard ratio (95% confidence interval) for 1-year mortality of 1.05 (0.83-1.32), and for the composite endpoint of 90-day post-discharge hospitalization or death of 0.97 (0.74-1.25). These results were consistent on the sensitivity analyses. CONCLUSIONS: Few patients with AHF present with RBBB, which is consistently associated with advanced age, male sex, pulmonary comorbidities, preserved left ventricular ejection fraction, and worse functional status. Nonetheless, after considering these factors, RBBB in AHF patients is not associated with worse outcomes.