RESUMEN
Heart failure with preserved ejection fraction (HFpEF) accounts for nearly half of all heart failure cases and has a prevalence that is expected to rise with the growing ageing population. HFpEF is associated with significant morbidity and mortality. Specific HFpEF risk factors include age, diabetes, hypertension, obesity and atrial fibrillation. Haemodynamic contributions to HFpEF include changes in left ventricular structure, diastolic and systolic dysfunction, left atrial myopathy, pulmonary hypertension, right ventricular dysfunction, chronotropic incompetence, and vascular dysfunction. Inflammation, fibrosis, impaired nitric oxide signalling, sarcomere dysfunction, and mitochondrial and metabolic defects contribute to the cellular and molecular changes observed in HFpEF. HFpEF impacts multiple organ systems beyond the heart, including the skeletal muscle, peripheral vasculature, lungs, kidneys and brain. The diagnosis of HFpEF can be made in individuals with signs and symptoms of heart failure with abnormality in natriuretic peptide levels or evidence of cardiopulmonary congestion, facilitated by the use of HFpEF risk scores and additional imaging and testing with the exclusion of HFpEF mimics. Management includes initiation of guideline-directed medical therapy and management of comorbidities. Given the significant impact of HFpEF on quality of life, future research efforts should include a particular focus on how patients can live better with this disease.
Asunto(s)
Insuficiencia Cardíaca , Volumen Sistólico , Humanos , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/diagnóstico , Volumen Sistólico/fisiología , Factores de Riesgo , Calidad de Vida/psicologíaRESUMEN
Cardiometabolic co-morbidities, diabetes (DM), hypertension (HTN), and obesity contribute to cardiovascular disease. Circulating biomarkers facilitate prognostication for patients with cardiovascular disease. We explored the relation between cardiometabolic co-morbidity burden in patients with chronic coronary disease and biomarkers of myocardial stretch, injury, inflammation, and platelet activity. We analyzed participants from the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trials biorepository with plasma biomarkers (N-terminal probrain natriuretic peptide, high-sensitivity cardiac troponin T, high-sensitivity C-reactive protein, interleukin-6, soluble CD40 ligand, and growth differentiation factor-15) and clinical risk factors (hemoglobin A1c [HbA1c], systolic blood pressure [SBP], and body mass index [BMI]) at baseline. We defined cardiometabolic co-morbidities as DM, HTN, and obesity at baseline. Co-morbidity burden is characterized by the number and severity of co-morbidities. Controlled co-morbidities were defined as HbA1c <7% for those with DM, SBP <130 mm Hg for those with HTN, and BMI <30 kg/m2. Severely uncontrolled was defined as HbA1c ≥8%, SBP ≥160 mm Hg, and BMI ≥35 kg/m2. We performed linear regression analyses to examine the association between co-morbidity burden and log-transformed biomarker levels, adjusting for age, gender, estimated glomerular filtration rate controlled for hemodialysis, and left ventricular ejection fraction. A total of 752 participants (mean age 66 years, 19% women, 84% White) were included in this analysis. Self-reported Black race, current smokers, history of myocardial infarction, and heart failure had a greater cardiometabolic co-morbidity burden. The presence of ≥1 severely uncontrolled co-morbidity was associated with significantly higher baseline levels of high-sensitivity cardiac troponin T, high-sensitivity C-reactive protein, interleukin-6, and growth differentiation factor-15 than participants with no co-morbidities. In conclusion, increasing cardiometabolic co-morbidity burden in patients with chronic coronary disease is associated with higher levels of circulating biomarkers of myocardial injury and inflammation.
Asunto(s)
Biomarcadores , Comorbilidad , Troponina T , Humanos , Femenino , Masculino , Biomarcadores/sangre , Persona de Mediana Edad , Anciano , Troponina T/sangre , Obesidad/epidemiología , Obesidad/complicaciones , Obesidad/sangre , Hipertensión/epidemiología , Hipertensión/sangre , Enfermedad Crónica , Proteína C-Reactiva/metabolismo , Proteína C-Reactiva/análisis , Diabetes Mellitus/epidemiología , Diabetes Mellitus/sangre , Hemoglobina Glucada/metabolismo , Enfermedad Coronaria/epidemiología , Enfermedad Coronaria/sangre , Factores de Riesgo Cardiometabólico , Fragmentos de Péptidos/sangre , Enfermedad de la Arteria Coronaria/sangre , Enfermedad de la Arteria Coronaria/epidemiología , Interleucina-6/sangre , Péptido Natriurético Encefálico/sangreRESUMEN
BACKGROUND: Despite advances in medical therapy for heart failure with reduced ejection fraction (HFrEF), major gaps in medication adherence to guideline-directed medical therapies (GDMT) remain. Greater continuity of care may impact medication adherence and reduced hospitalizations. METHODS: We conducted a cross-sectional study of adults with a diagnosis of HF and EF ≤40% with ≥2 outpatient encounters between January 1, 2017 and January 10, 2021, prescribed ≥1 of the following GDMT: 1) Beta Blocker, 2) Angiotensin Converting Enzyme Inhibitor/Angiotensin Receptor Blocker/Angiotensin Receptor Neprilysin Inhibitor, 3) Mineralocorticoid Receptor Antagonist, 4) Sodium Glucose Cotransporter-2 Inhibitor. Continuity of care was calculated using the Bice-Boxerman Continuity of Care Index (COC) and the Usual Provider of Care (UPC) index, categorized by quantile. The primary outcome was adherence to GDMT, defined as average proportion of days covered ≥80% over 1 year. Secondary outcomes included all-cause and HF hospitalization at 1-year. We performed multivariable logistic regression analyses adjusted for demographics, insurance status, comorbidity index, number of visits and neighborhood SES index. RESULTS: Overall, 3,971 individuals were included (mean age 72 years (SD 14), 71% male, 66% White race). In adjusted analyses, compared to individuals in the highest COC quartile, individuals in the third COC quartile had higher odds of GDMT adherence (OR 1.26, 95% CI 1.03-1.53, P = .024). UPC tertile was not associated with adherence (all P > .05). Compared to the highest quantiles, the lowest UPC and COC quantiles had higher odds of all-cause (UPC: OR 1.53, 95%CI 1.23-1.91; COC: OR 2.54, 95%CI 1.94-3.34) and HF (UPC: OR 1.81, 95%CI 1.23-2.67; COC: OR 1.77, 95%CI 1.09-2.95) hospitalizations. CONCLUSIONS: Continuity of care was not associated with GDMT adherence among patients with HFrEF but lower continuity of care was associated with increased all-cause and HF-hospitalizations.
Asunto(s)
Continuidad de la Atención al Paciente , Insuficiencia Cardíaca , Cumplimiento de la Medicación , Humanos , Insuficiencia Cardíaca/tratamiento farmacológico , Masculino , Femenino , Cumplimiento de la Medicación/estadística & datos numéricos , Estudios Transversales , Continuidad de la Atención al Paciente/estadística & datos numéricos , Anciano , Persona de Mediana Edad , Hospitalización/estadística & datos numéricos , Antagonistas Adrenérgicos beta/uso terapéutico , Volumen Sistólico , Antagonistas de Receptores de Angiotensina/uso terapéutico , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Antagonistas de Receptores de Mineralocorticoides/uso terapéuticoRESUMEN
BACKGROUND: Cardiometabolic risk factors diabetes, obesity, and hypertension are highly prevalent and contribute to increased cardiovascular disease (CVD). Endothelial dysfunction precedes CVD development. The current study aimed to investigate the EC transcriptome among individuals with varying degree of cardiometabolic risk. METHODS: Adult participants without CVD and various degrees of cardiometabolic risk factor burden (hypertension, diabetes, obesity) were included. Participants underwent brachial vein EC harvesting followed by RNA sequencing. To evaluate the association between cardiometabolic comorbidity burden and outcome transcripts we performed linear regression with multivariable models, adjusting for age, sex, and race/ethnicity. RESULTS: A total of 18 individuals were included in the present analysis (mean age 47 ± 14, 44% female, and 61% White adults). Endothelial cell RNA sequencing revealed 588 differentially expressed transcripts (p-adj <0.05) with excellent discrimination in unsupervised hierarchical clustering analysis. Gene ontology enrichment analysis revealed upregulated pathways associated with T-cell activation (NESâ¯=â¯2.22, p<0.001), leukocyte differentiation (NES= 2.16, p<0.001), leukocyte migration (NES= 2.12, p<0.001), regulation of cell-cell adhesion (NES= 1.91, p=0.006). Downregulated pathways of interest included endothelial cell proliferation (NES= -1.68, p=0.03) and response to interleukin-1 (NES= -1.61, p=0.04). Upregulated genes included VCAM1, CEACAM1, ADAM 17, and CD99L2, all with a log-2-fold change >3 and p-adj <0.05. These genes demonstrated a graded increase in mean normalized counts with increasing number of risk factors. CONCLUSIONS: We demonstrate a proinflammatory and pro-adhesive EC transcriptome associated with increased cardiometabolic risk factor burden offering insight into a potential mechanism linking these risk factors with the development of CVD.
Asunto(s)
Enfermedades Cardiovasculares , Diabetes Mellitus , Hipertensión , Adulto , Humanos , Femenino , Persona de Mediana Edad , Masculino , Factores de Riesgo Cardiometabólico , Factores de Riesgo , Hipertensión/complicaciones , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/genética , Obesidad/complicacionesRESUMEN
Acute decompensated heart failure (ADHF) is one of the most common reasons for hospitalizations or urgent care and is associated with poor outcomes. Therapies shown to improve outcomes are limited, however, and innovation in pharmacologic and device-based therapeutics are therefore actively being sought. Standardizing definitions for ADHF and its trajectory is complex, limiting the generalizability and translation of clinical trials to effect clinical care and policy change. The Heart Failure Collaboratory is a multistakeholder organization comprising clinical investigators, clinicians, patients, government representatives (including U.S. Food and Drug Administration and National Institutes of Health participants), payors, and industry collaborators. The following expert consensus document is the product of the Heart Failure Collaboratory convening with the Academic Research Consortium, including members from academia, the U.S. Food and Drug Administration, and industry, for the purposes of proposing standardized definitions for ADHF and highlighting important endpoint considerations to inform the design and conduct of clinical trials for drugs and devices in this clinical arena.
Asunto(s)
Insuficiencia Cardíaca , Implantación de Prótesis de Válvulas Cardíacas , Humanos , Insuficiencia Cardíaca/terapia , HospitalizaciónRESUMEN
BACKGROUND: Diabetes exerts adverse effects on the heart, and a longer diabetes duration is associated with greater heart failure risk. We studied diabetes duration and subclinical myocardial injury, as reflected by high-sensitivity cardiac troponin (hs-cTnT). METHODS: We analyzed 9052 participants without heart failure or coronary heart disease (mean age 63 years, 58% female, 21% Black, 15% with diabetes) at The Atherosclerosis Risk in Communities Study (ARIC) Visit 4 (1996 to 1998). Diabetes duration was calculated based on diabetes status at Visits 1 (1987 to 1989) through 4, or using self-reported age of diabetes diagnosis prior to Visit 1. We used multinomial logistic regression to determine the association of diabetes duration with increased (≥14 ng/L) or detectable (≥6 ng/L) Visit 4 hs-cTnT, relative to undetectable hs-cTnT, adjusted for demographics and cardiovascular risk factors. RESULTS: The prevalence of increased Visit 4 hs-cTnT was higher in persons with longer diabetes duration, from 12% for those with diabetes 0 to <5 years up to 31% among those with diabetes for ≥15 years (P for trend <0.0001). New onset diabetes at Visit 4 was associated with 1.92× higher relative risk (95% CI, 1.27-2.91) of increased hs-cTnT than no diabetes. Longer diabetes duration was associated with greater myocardial injury, with duration ≥15 years associated with 9.29× higher risk (95% CI, 5.65-15.29) for increased hs-cTnT and 2.07× (95% CI, 1.24-3.16) for detectable hs-cTnT, compared to no diabetes. CONCLUSIONS: Longer diabetes duration is strongly associated with subclinical myocardial injury. Interventional studies are needed to assess whether the prevention and delay of diabetes onset can mitigate early myocardial damage.
Asunto(s)
Aterosclerosis , Diabetes Mellitus , Insuficiencia Cardíaca , Aterosclerosis/complicaciones , Aterosclerosis/epidemiología , Biomarcadores , Diabetes Mellitus/epidemiología , Femenino , Insuficiencia Cardíaca/etiología , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Troponina TRESUMEN
With the current landscape of approved therapies for heart failure (HF), there is a need to determine the role of a standard background therapy against which novel therapies are studied. The Heart Failure Collaboratory convened a multistakeholder group of clinical investigators, clinicians, patients, government representatives including U.S. Food and Drug Administration and National Institutes of Health participants, payers, and industry in March 2021 to discuss whether standardization of background drug therapy is necessary in clinical trials in patients with HF. The current paper summarizes the discussion and provides potential conceptual approaches, with a focus on therapies indicated for HF with reduced ejection fraction.
Asunto(s)
Fármacos Cardiovasculares/uso terapéutico , Ensayos Clínicos como Asunto , Insuficiencia Cardíaca/tratamiento farmacológico , Publicaciones Periódicas como Asunto , Volumen Sistólico/fisiología , Insuficiencia Cardíaca/fisiopatología , HumanosRESUMEN
Heart failure (HF) continues to be a major contributor of morbidity and mortality for men and women alike, yet how the predisposition for, course and management of HF differ between men and women remains underexplored. Sex differences in traditional risk factors as well as sex-specific risk factors influence the prevalence and manifestation of HF in unique ways. The pathophysiology of HF differs between men and women and may explain sex-specific differences in clinical presentation and diagnosis. This in turn, contributes to variation in response to both pharmacologic and device/surgical therapy. This review examines sex-specific differences in HF spanning prevalence, risk factors, pathophysiology, presentation, and therapies with a specific focus on highlighting gaps in knowledge with calls to action for future research efforts.
Asunto(s)
Insuficiencia Cardíaca , Femenino , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/terapia , Humanos , Masculino , Factores de Riesgo , Caracteres Sexuales , Factores SexualesRESUMEN
BACKGROUND: Hospitalization for acute decompensated heart failure (ADHF) remains a major source of morbidity and mortality. The current study aimed to investigate the feasibility, safety, and efficacy of outpatient furosemide intravenous (IV) infusion following hospitalization for ADHF. METHODS: In a single center, prospective, randomized, double-blind study, 100 patients were randomized to receive standard of care (Group 1), IV placebo infusion (Group 2), or IV furosemide infusion (Group 3) over 3h, biweekly for a one-month period following ADHF hospitalization. Patients in Groups 2/3 also received a comprehensive HF-care protocol including bi-weekly clinic visits for dose-adjusted IV-diuretics, medication adjustment and education. Echocardiography, quality of life and depression questionnaires were performed at baseline and 30-day follow-up. The primary outcome was 30-day re-hospitalization for ADHF. RESULTS: Overall, a total of 94 patients were included in the study (mean age 64 years, 56% males, 69% African American). There were a total of 14 (15%) hospitalizations for ADHF at 30 days, 6 (17.1%) in Group 1, 7 (22.6%) in Group 2, and 1 (3.7%) in Group 3 (overall p = 0.11; p = 0.037 comparing Groups 2 and 3). Patients receiving IV furosemide infusion experienced significantly greater urine output and weight loss compared to those receiving placebo without any significant increase creatinine and no significant between group differences in echocardiography parameters, KCCQ or depression scores. CONCLUSION: The use of a standardized protocol of outpatient IV furosemide infusion for a one-month period following hospitalization for ADHF was found to be safe and efficacious in reducing 30-day re-hospitalization.
Asunto(s)
Diuréticos/administración & dosificación , Insuficiencia Cardíaca/tratamiento farmacológico , Hospitalización/estadística & datos numéricos , Pacientes Ambulatorios/estadística & datos numéricos , Calidad de Vida , Anciano , Método Doble Ciego , Femenino , Insuficiencia Cardíaca/patología , Humanos , Infusiones Intravenosas , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Inhibidores del Simportador de Cloruro Sódico y Cloruro Potásico , Resultado del TratamientoRESUMEN
BACKGROUND: Postdischarge mortality following hospitalization for heart failure with reduced ejection fraction (HFrEF) has remained high and unchanged over the past 2 decades, despite effective therapies for HFrEF. We aimed to explore whether these patterns could in part be explained by changes in longitudinal risk profile and HF severity over time. METHODS: Among patients hospitalized for HF in the GWTG-HF registry from January 2005 to December 2018 with available data, we evaluated GWTG-HF and ADHERE risk scores, observing in-hospital mortality per-year. The risk profiles and outcomes were described overall and by subgroups based on ejection fraction (EF), diabetes mellitus (DM), sex, and age. RESULTS: Overall, 335,735 patients were included (50% HFrEF, 46% DM, 48% female, mean age 74 years). In-hospital mortality increased by 2.0% per year from 2005 to 2018. There was no significant change in mean GWTG-HF risk score overall or when stratified by EF groups (Pâ¯=â¯0.46 HFrEF, pâ¯=â¯0.26 HF mid-range EF [HFmrEF], and Pâ¯=â¯0.72 HF preserved EF [HFpEF]), age, sex, or presence of DM. The observed/expected ratio based on the GWTG-HF risk score was 0.93 (0.91-0.96), 0.83 (0.77-0.90), 0.92 (0.89-95) for HFrEF, HFmrEF, and HFpEF, respectively. Similar findings were seen when risk was assessed using ADHERE risk score. CONCLUSIONS: There were no significant changes in average risk profiles among hospitalized HF patients over the study duration. These data do not support the notion that worsening risk profile explains the lack of improved outcomes despite therapeutic advances, underscoring the importance of aggressive implementation of guideline-recommended therapies and investigation of novel treatments.
Asunto(s)
Insuficiencia Cardíaca/fisiopatología , Mortalidad Hospitalaria/tendencias , Negro o Afroamericano , Factores de Edad , Anciano , Anciano de 80 o más Años , Presión Sanguínea , Nitrógeno de la Urea Sanguínea , Comorbilidad , Diabetes Mellitus/epidemiología , Femenino , Insuficiencia Cardíaca/sangre , Insuficiencia Cardíaca/epidemiología , Frecuencia Cardíaca , Hispánicos o Latinos , Hospitalización , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Enfermedad Pulmonar Obstructiva Crónica , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores Sexuales , Sodio/sangre , Volumen Sistólico , Población BlancaRESUMEN
Background: Medical education is rapidly changing where there has been decreased emphasis on passive didactics and increased focus on novel modes of teaching and learning to address the unique needs of millennial learners. As educators, it is challenging to keep up and find active teaching strategies outside of routine small group exercises to engage learners. Although the traditional small group activities, such as cased-based learning, allows for interactive and effective teaching, this modality may require the use of multiple faculty facilitators, which can be a difficult resource to find. The jigsaw learning method is cooperative learning that utilizes peer teaching and promotes collaborative learning, and additionally, only one facilitator is required of this type of learning technique.Objectives: We aimed to assess the effectiveness of the jigsaw method by comparing it to the traditional small group learning method to teach principles of diagnostic reasoning. Design: Residents were assigned to either the traditional small group teaching method or the jigsaw method. We compared pre-test, post-test, one-year follow-up test results between participants, and resident perception of the exercises.Results: A 2 × 3 repeated measures ANOVA indicated statistically significant improvement in tests scores from before to after participation with the jigsaw method compared to the traditional small group method. Post-survey demonstrated higher resident satisfaction with the jigsaw method.Conclusion: Our study demonstrates that a jigsaw cooperative learning approach can be used as an effective method to promote collaborative learning and engagement.
Asunto(s)
Internado y Residencia/organización & administración , Seguridad del Paciente , Enseñanza/organización & administración , Conducta Cooperativa , Curriculum , Femenino , Procesos de Grupo , Humanos , Internado y Residencia/normas , Aprendizaje , Masculino , Grupo Paritario , Satisfacción Personal , Enseñanza/normasRESUMEN
The prevalence of heart failure continues to grow, and this is accompanied by an increase in hospitalization for acute heart failure. Hospitalization for heart failure results in a trajectory shift of the syndrome and is associated with worsening outcomes, increased mortality risk, and high costs. Numerous clinical trials over the past 2 decades have had limited success, with no single agent shown to improve mortality risk. The lack of success is multifactorial and in part related to inadequate targets and end points selected for intervention, underscoring the need to better understand and define the pathophysiology of acute heart failure. To better inform future drug development, this review critically explores the short-term end points and outcomes that previous phase III acute heart failure trials have examined.
Asunto(s)
Ensayos Clínicos como Asunto , Determinación de Punto Final/métodos , Insuficiencia Cardíaca/epidemiología , Hospitalización/estadística & datos numéricos , Enfermedad Aguda , Salud Global , Insuficiencia Cardíaca/terapia , Humanos , Prevalencia , Tasa de Supervivencia/tendenciasRESUMEN
BACKGROUND: Although the American Council of Graduate Medical Education (ACGME) mandates formal education in patient safety, there is a lack of standardized educational practice on how to conduct patient safety training. Traditionally, patient safety is taught utilizing instructional strategies that promote passive learning such as self-directed online learning modules or didactic lectures that result in suboptimal learning and satisfaction. METHODS: During the summer of 2015, 76 trainees consisting of internal medicine interns and senior-level nursing students participated in an interactive patient safety workshop that used a flipped classroom approach integrating team based learning (TBL) and interprofessional simulated application exercises. RESULTS: Workshop trainees demonstrated an increase in knowledge specifically related to patient safety core concepts on the Team Readiness Assurance Test (TRAT) compared to the Individual Readiness Assurance Test (IRAT) (p = 0.001). Completion rates on the simulation application exercises checklists were high except for a few critical action items such as hand-washing, identifying barriers to care, and making efforts to clarify code status with patient. The Readiness for Interprofessional Learning Scale (RIPLS) subscale scores for Teamwork and Collaboration and Professional Identity were higher on the post-workshop survey compared to the pre-workshop survey, however only the difference in the Positive Professional Identity subscale was statistically significant (p = 0.03). A majority (90%) of the trainees either agreed that the safety concepts they learned would likely improve the quality of care they provide to future patients. CONCLUSIONS: This novel approach to safety training expanded teaching outside of the classroom and integrated simulation and engagement in error reduction strategies. Next steps include direct observation of trainees in the clinical setting for team-based competency when it comes to patient safety and recognition of system errors.
Asunto(s)
Educación Médica/normas , Educación en Enfermería/normas , Seguridad del Paciente/normas , Simulación de Paciente , Lista de Verificación , Humanos , Medicina Interna/educación , Aprendizaje , Estudiantes de Medicina , Estudiantes de EnfermeríaRESUMEN
Cancer and cardiovascular disease account for nearly half of all deaths in the US. The majority of cancer therapies are known to cause potential cardiac toxicity in some form. Patients with underlying cardiac disease are at a particularly increased risk for worse outcomes following cancer therapy. Most alarming is the potential for heart failure as a result of cancer treatment, which may lead to early disruption or withdrawal of life-saving cancer therapies and can potentially increase cardiovascular mortality. A multi-disciplinary cardio-oncology approach can improve outcomes through early surveillance, prevention and treatment strategies.
RESUMEN
Heart failure (HF) and type 2 diabetes mellitus (T2DM) are both growing public health concerns contributing to major medical and economic burdens to society. T2DM increases the risk of HF, frequently occurs concomitantly with HF, and worsens the prognosis of HF. Several anti-hyperglycaemic medications have been associated with a concern for worse HF outcomes. More recently, the results of the EMPA-REG OUTCOME trial showed that the sodium-glucose co-transporter 2 (SGLT2) inhibitor empagliflozin was associated with a pronounced and precocious 38% reduction in cardiovascular mortality in subjects with T2DM and established cardiovascular disease [Correction added on 8 September 2017, after first online publication: "32%" in the previous sentence was corrected to "38%"]. These benefits were more related to a reduction in incident HF events rather than to ischaemic vascular endpoints. Several mechanisms have been put forward to explain these benefits, which also raise the possibility of using these drugs as therapies not only in the prevention of HF, but also for the treatment of patients with established HF regardless of the presence or absence of diabetes. Several large trials are currently exploring this postulate.
Asunto(s)
Compuestos de Bencidrilo/uso terapéutico , Glucósidos/uso terapéutico , Insuficiencia Cardíaca/tratamiento farmacológico , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Hipoglucemiantes/uso terapéutico , Sodio , Transportador 2 de Sodio-Glucosa , Resultado del TratamientoRESUMEN
PURPOSE OF REVIEW: With the growing prevalence of heart failure, there is a particular need to develop new pharmacologic treatments that can improve outcomes. While there are several approved therapies for heart failure with reduced ejection fraction, there is currently no approved agent for those with preserved ejection fraction. The current review aimed to explore the utility of alternate endpoints to mortality and hospitalization. RECENT FINDINGS: There is increased interest in the use of alternative endpoints such as functional status and quality of life for heart failure drug development to focus on patients feeling better in addition to improving outcomes. This should ideally be measured using objective as well as subjective parameters. While mortality and hospitalization remain important endpoints for clinical trials in heart failure, other more patient-centered outcomes are attractive alternatives yet how to best incorporate these in a trial setting remains to be elucidated.
Asunto(s)
Insuficiencia Cardíaca/tratamiento farmacológico , Volumen Sistólico/fisiología , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/fisiopatología , Hospitalización , Humanos , Atención Dirigida al Paciente , Calidad de Vida , Resultado del TratamientoRESUMEN
Heart Failure (HF) is a serious emerging Public Health issue mainly in the high-income countries. In the USA, more than 6 million adults are affected. Despite the latest advances in device and pharmacological therapeutics, it still carries a huge burden, partially reflected in the annual healthcare cost of approximately $30 billion (2012) and the 5 year mortality rate of 50%. In this article, we review the medications, proven to significantly reduce mortality and morbidity in HF patients with structural myocardial disease and past or current symptoms, based on the latest North American HF guidelines. We, finally, perform a brief comparison between the former recommendations and the published 2016 HF guidelines by European Society of Cardiology.
Asunto(s)
Antagonistas Adrenérgicos beta/uso terapéutico , Antagonistas de Receptores de Angiotensina/uso terapéutico , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Fármacos Cardiovasculares/uso terapéutico , Diuréticos/uso terapéutico , Insuficiencia Cardíaca/tratamiento farmacológico , Antagonistas de Receptores de Mineralocorticoides/uso terapéutico , Vasodilatadores/uso terapéutico , Aminobutiratos/uso terapéutico , Benzazepinas/uso terapéutico , Compuestos de Bifenilo , Combinación de Medicamentos , Insuficiencia Cardíaca/fisiopatología , Humanos , Hidralazina/uso terapéutico , Ivabradina , Neprilisina/antagonistas & inhibidores , Nitratos/uso terapéutico , Guías de Práctica Clínica como Asunto , Índice de Severidad de la Enfermedad , Volumen Sistólico , Tetrazoles/uso terapéutico , ValsartánRESUMEN
The increasing burden and the continued suboptimal outcomes for patients with heart failure underlines the importance of continued research to develop novel therapeutics for this disorder. This can only be accomplished with successful translation of basic science discoveries into direct human application through effective clinical trial design and execution that results in a substantially improved clinical course and outcomes. In this respect, phase II clinical trials play a pivotal role in determining which of the multitude of potential basic science discoveries should move to the large and expansive registration trials in humans. A critical examination of the phase II trials in heart failure reveals multiple shortcomings in their concept, design, execution, and interpretation. To further a dialogue on the challenges and potential for improvement and the role of phase II trials in patients with heart failure, the Food and Drug Administration facilitated a meeting on October 17, 2016, represented by clinicians, researchers, industry members, and regulators. This document summarizes the discussion from this meeting and provides key recommendations for future directions.
Asunto(s)
Fármacos Cardiovasculares/uso terapéutico , Ensayos Clínicos Fase II como Asunto/normas , Insuficiencia Cardíaca/tratamiento farmacológico , Proyectos de Investigación/normas , Fármacos Cardiovasculares/efectos adversos , Ensayos Clínicos Fase II como Asunto/métodos , Consenso , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/fisiopatología , Humanos , Resultado del Tratamiento , Estados Unidos , United States Food and Drug AdministrationRESUMEN
Heart Failure is a global epidemic, affecting approximately 5 million adults in the U.S.A. The cornerstone of contemporary pharmacological therapy targets the over activated renin-angiotensin-aldosterone and sympathetic autonomic systems. The 2016 focused pharmacologic update on the current Heart Failure Guidelines introduces the use of two newly approved regimens valsartan/sacubitril and ivabradine. Over the last two decades, guideline directed medical therapy has accomplished significant improvement in survival rates among heart failure patients; however these novel compounds were reported to exert additional mortality and morbidity benefits, in heart failure subpopulations with reduced ejection fraction.