Carbohydrate Antigen-125-Guided Therapy in Acute Heart Failure: CHANCE-HF: A Randomized Study.

OBJECTIVES: This study sought to evaluate the prognostic effect of carbohydrate antigen-125 (CA125)-guided therapy (CA125 strategy) versus standard of care (SOC) after a hospitalization for acute heart failure (AHF). BACKGROUND: CA125 has emerged as a surrogate of fluid overload and inflammatory status in AHF. After an episode of AHF admission, elevated values of this marker at baseline as well as its longitudinal profile relate to adverse outcomes, making it a potential tool for treatment guiding. METHODS: In a prospective multicenter randomized trial, 380 patients discharged for AHF and high CA125 were randomly assigned to the CA125 strategy (n = 187) or SOC (n = 193). The aim in the CA125 strategy was to reduce CA125 to ≤35 U/ml by up or down diuretic dose, enforcing the use of statins, and tightening patient monitoring. The primary endpoint was 1-year composite of death or AHF readmission. Treatment strategies were compared as a time to first event and longitudinally. RESULTS: Patients allocated to the CA125 strategy were more frequently visited, and treated with ambulatory intravenous loop diuretics and statins. Likewise, doses of oral loop diuretics and aldosterone receptor blockers were more frequently modified. The CA125 strategy resulted in a significant reduction of the primary endpoint, whether evaluated as time to first event (66 events vs. 84 events; p = 0.017) or as recurrent events (85 events vs. 165 events; incidence rate ratio: 0.49; 95% confidence interval: 0.28 to 0.82; p = 0.008). The effect was driven by significantly reducing rehospitalizations but not mortality. CONCLUSIONS: The CA125 strategy was superior to the SOC in terms of reducing the risk of the composite of 1-year death or AHF readmission. This effect was mainly driven by significantly reducing the rate of rehospitalizations. (Carbohydrate Antigen-125-guided Therapy in Heart Failure [CHANCE-HF]; NCT02008110).

Predictors of obstetric complications in women with heart disease.

OBJECTIVES: The objective of this study is to evaluate obstetric outcomes in women with heart disease and determine whether current multidisciplinary management approaches adversely affect the mother, the neonate, or both. Also to compare the accuracy of several risk scores (RS) including the modified World Health Organization classification (mWHO) and CARPREG to predict obstetric and neonatal complications and to study the addition value of Uteroplacental-Doppler flow (UDF) parameters to predict obstetric complications. METHODS: A prospective cohort study examined outcomes in women with heart disease (HD), the majority of whom had corrective surgery and delivered between January 2007 and March 2012. RESULTS: One hundred and seventy-four patients with 179 pregnancies were included in the study. Obstetric complications, including premature labor, arose in 87 patients (48.6%). Neonatal complications were observed in 11 cases (7%). On multivariate analysis, maternal heart disease was predictive of adverse perinatal events (46 cases, 25.7%) and mode of delivery (Thierry's spatula) of third- or fourth-degree perineal tears (six cases, 3.2%). mWHO classification predicted obstetric complications (p = 0.0001) better than the CARPREG study. Impaired UDF (uterine artery pulsatility index-20 weeks and umbilical artery pulsatility index-32 weeks in HD versus healthy women: 20w 1.12 versus 1.34, p = 0.005; 32w 0.87 versus 1.09, p = 0.008) was associated with adverse obstetric and offspring outcome in the group of HD pregnant women. CONCLUSIONS: Nearly 50% of pregnancies were associated with an adverse obstetric outcome, particularly IUGR. mWHO was better at predicting obstetric and neonatal complications that CARPREG in all categories. Furthermore, compromised UDF combined with mWHO improved the prediction of obstetric and offspring complications in this population.

Efecto pronóstico de una estrategia terapéutica guiada por los valores del antígeno carbohidrato 125 (CHANCE-HF). Diseño del estudio / Prognostic effect of carbohydrate antigen 125-guided therapy in patients recently discharged for acute heart failure (CHANCE-HF). Study design

Introducción y objetivos La morbilidad y la mortalidad después de un ingreso por insuficiencia cardiaca aguda siguen siendo extremadamente elevadas. En este contexto, se ha demostrado que las concentraciones plasmáticas del antígeno carbohidrato 125 muestran correlación con la gravedad de la sobrecarga hídrica y el riesgo de muerte y reingreso. Los datos preliminares indican un posible papel del antígeno carbohidrato 125 como guía para el tratamiento. El objetivo de este estudio es evaluar el efecto pronóstico de una estrategia de tratamiento guiada por el antígeno carbohidrato 125 comparada con el tratamiento estándar en pacientes dados de alta recientemente tras un ingreso por insuficiencia cardiaca aguda. Métodos Ensayo clínico multicéntrico, aleatorizado y a ciego simple, de evaluación de la eficacia en pacientes recientemente dados de alta tras una insuficiencia cardiaca aguda (< 180 días), en clase funcional II-IV de la New York Heart Association y con antígeno carbohidrato 125 > 35 U/ml. Se utilizó un esquema de aleatorización para asignar a los participantes (en relación 1:1) a tratamiento guiado por el antígeno carbohidrato 125 (destinado a mantener valores normales) o tratamiento estándar. El tratamiento guiado se centra principalmente en la frecuencia de monitorización y ajuste de dosis de los tratamientos descongestivos y las estatinas. Hasta el 10 de diciembre de 2013, se había incluido en el estudio a 383 pacientes. El objetivo principal era la combinación de mortalidad por cualquier causa o rehospitalización por insuficiencia cardiaca aguda a 1 año. Se planificó el análisis según el criterio de intención de tratar. Conclusiones: El descubrimiento de estrategias terapéuticas novedosas o mejores formas de optimizar los tratamientos establecidos ha pasado a ser una prioridad de la asistencia sanitaria en la insuficiencia cardiaca. Este estudio aporta nuevos conocimientos importantes acerca del potencial del antígeno carbohidrato 125 como instrumento útil para la monitorización y ajuste de la posología de los tratamientos en los casos en que la utilización óptima no está bien definida, como ocurre con los diuréticos y las estatinas

Introduction and objectives Morbidity and mortality after admission for acute heart failure remain prohibitively high. In that setting, plasma levels of antigen carbohydrate 125 have shown to correlate with the severity of fluid overload and the risk of mortality and readmission. Preliminary data suggests a potential role of antigen carbohydrate 125 to guide therapy. The objective of this study is to evaluate the prognostic effect of an antigen carbohydrate 125-guided management strategy vs standard therapy in patients recently discharged for acute heart failure. Methods This is a multicenter, randomized, single-blind, efficacy trial study of patients recently discharged from acute heart failure (< 180 days), New York Heart Association functional class II-IV and antigen carbohydrate 125 > 35 U/ml. A randomization scheme was used to allocate participants (in a 1:1 ratio) to receive therapy guided by antigen carbohydrate 125 (aiming to keep normal values) or standard treatment. Mainly, antigen carbohydrate 125-guided therapy is focused on the frequency of monitoring and titration of decongestive therapies and statins. As of December 10, 2013, there were 383 patients enrolled. The primary outcome was the composite of 1-year all-cause mortality or rehospitalization for acute heart failure. Analysis was planned to be intention-to-treat. Conclusions Discovering novel therapeutic strategies or finding better ways of optimizing established treatments have become a health care priority in heart failure. This study will add important knowledge about the potential of antigen carbohydrate 125 as a management tool for monitoring and titration of therapies where optimal utilization has not been well defined, such as diuretics and statins (AU)

Prognostic effect of carbohydrate antigen 125-guided therapy in patients recently discharged for acute heart failure (CHANCE-HF). Study design.

INTRODUCTION AND OBJECTIVES: Morbidity and mortality after admission for acute heart failure remain prohibitively high. In that setting, plasma levels of antigen carbohydrate 125 have shown to correlate with the severity of fluid overload and the risk of mortality and readmission. Preliminary data suggests a potential role of antigen carbohydrate 125 to guide therapy. The objective of this study is to evaluate the prognostic effect of an antigen carbohydrate 125-guided management strategy vs standard therapy in patients recently discharged for acute heart failure. METHODS: This is a multicenter, randomized, single-blind, efficacy trial study of patients recently discharged from acute heart failure (< 180 days), New York Heart Association functional class II-IV and antigen carbohydrate 125 > 35 U/ml. A randomization scheme was used to allocate participants (in a 1:1 ratio) to receive therapy guided by antigen carbohydrate 125 (aiming to keep normal values) or standard treatment. Mainly, antigen carbohydrate 125-guided therapy is focused on the frequency of monitoring and titration of decongestive therapies and statins. As of December 10, 2013, there were 383 patients enrolled. The primary outcome was the composite of 1-year all-cause mortality or rehospitalization for acute heart failure. Analysis was planned to be intention-to-treat. CONCLUSIONS: Discovering novel therapeutic strategies or finding better ways of optimizing established treatments have become a health care priority in heart failure. This study will add important knowledge about the potential of antigen carbohydrate 125 as a management tool for monitoring and titration of therapies where optimal utilization has not been well defined, such as diuretics and statins. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT02008110.