Optimal background pharmacological therapy for heart failure patients in clinical trials: JACC review topic of the week

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

Getting to the Heart of the Matter: An Overview of Cardiac Toxicity Related to Cancer Therapy

With the improvement in cancer survival, long-term cardiotoxicity has become an area of increased interest. Various cancer therapies, including chemotherapy and radiation therapy can lead to cardiac toxicities with both acute and chronic manifestations. Awareness and early recognition can lead to improvement in cardiac survival and patient outcomes. The focus of this review is to summarize the cancer therapy agents most often associated with cardiovascular side effects, highlighting their mechanism of action and strategies for surveillance and prevention

Effectiveness of an interprofessional patient safety team-based learning simulation experience on healthcare professional trainees

Abstract 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

A Critical Appraisal of Short-Term End Points in Acute Heart Failure Clinical Trials

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

Baseline Distribution of Participants with Depression and Impaired Quality of Life in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist Trial

BACKGROUND: Previous studies have demonstrated the psychosocial effect of heart failure in patients with reduced ejection fraction. However, the effects on patients with preserved ejection fraction have not yet been elucidated. This study aimed to determine the baseline characteristics of participants with heart failure with preserved ejection fraction as it relates to impaired quality of life (QOL) and depression, identify predictors of poor QOL and depression, and determine the correlation between QOL and depression. METHODS AND RESULTS: Among patients enrolled in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial (TOPCAT), 3400 patients completed the Kansas City Cardiomyopathy Questionnaire, 3395 patients completed European QOL 5D Visual Analog Scale, and 1431 patients in United States and Canada completed the Patient Health Questionnaire-9. The mean summary score on the Kansas City Cardiomyopathy Questionnaire was 54.8, and on European QOL 5D Visual Analog Scale, it was 60.3; 27% of patients had moderate to severe depression. Factors associated with better Kansas City Cardiomyopathy Questionnaire and European QOL 5D Visual Analog Scale via multiple logistic regression analysis were American region, older age, no history of angina pectoris or asthma, no use of hypoglycemic agent, more activity level, and lower New York Heart Association class. Factors associated with depression via multiple logistic regression analysis included younger age, female sex, comorbid angina, chronic obstructive pulmonary disease, use of a hypoglycemic agent, lower activity level, higher New York Heart Association class, and selective serotonin reuptake inhibitor use. There were significant correlations between each of the QOL scores and depression. CONCLUSIONS: Patients with heart failure with preserved ejection fraction, who were younger had higher New York Heart Association class or comorbid angina pectoris, had lower activity levels, lived in Eastern Europe or were taking hypoglycemic agents, were more likely to have impaired QOL and depression. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00094302

Temporal trends in risk profiles among patients hospitalized for heart failure

BackgroundPostdischarge 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.MethodsAmong 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.ResultsOverall, 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 (P = 0.46 HFrEF, p = 0.26 HF mid-range EF [HFmrEF], and P = 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.ConclusionsThere 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