Association of Double-Blind Reviews with Increases in Women as First Authors: An Initial Report from the Journal of Cardiac Failure.

INTRODUCTION: Women continue to remain under-represented in academic publishing in cardiology. Some evidence suggests that double-blind peer reviews may mitigate the impact of gender bias. In July 2021, the Journal of Cardiac Failure implemented a process for the conduct of double-blind reviews after previously utilizing single-blind reviews with the aim of improving author diversity. The purpose of the current manuscript was to examine the association between changes in authorship characteristics and implementation of double-blind reviews. METHODS: Manuscripts were stratified into 3 eras: March - September 2021 (Era 1 - prior to double blind reviews), March - September 2022 (Era 2), and March - September 2023 (Era 3). All article types except invited editorials were included. Data were abstracted, including names, genders, ranks, and discipline of first and senior authors. RESULTS: A total of 310 manuscripts were included in the analysis. The proportion of women first authors increased from 24% in Era 1 to 34% in Era 2 to 39% in Era 3 while the percentage of women authors serving in a senior authorship role remained fairly stable over time around 21-22%. Even after adjusting for region, article type, first author discipline, and last author gender, there was an increase in female first author over time (p= 0.015). Manuscripts with a female senior author were significantly more likely to have a female first author. CONCLUSIONS: Our findings suggest that double-blind peer review may contribute to increased gender diversity of first authors and highlight areas for future improvement for JCF and academic publishing.

Rationale and Design of the SOTA-P-CARDIA Trial (ATRU-V): Sotagliflozin in HFpEF Patients Without Diabetes.

Heart failure with preserved ejection fraction (HFpEF) is now the most common form of heart failure (HF). This syndrome is associated with an elevated morbi-mortality, and effective therapies are urgently needed. Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are the first pharmacological class that has demonstrated to reduce hospitalization and cardiovascular mortality in large clinical trials in HFpEF. Furthermore, the dual SGLT 1/2 inhibitor sotagliflozin has shown a reduction in cardiovascular outcomes in diabetic HF patients, regardless of ejection fraction Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF) Trial, and prevents the development of HF in patients with diabetes and chronic kidney disease Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk (SCORED) trial. The major objective of the Sotagliflozin in Heart Failure With Preserved Ejection Fraction Patients (SOTA-P-CARDIA) trial (NCT05562063) is to investigate whether the observed cardiorenal benefits of sotagliflozin in HF patients with diabetes can be extended to a non-diabetic population. The SOTA-P-CARDIA is a prospective, randomized, double-blinded, placebo-controlled study that will randomize non-diabetic patients with the universal definition of HFpEF (ejection fraction > 50% assessed the day of randomization). Qualifying patients will be randomized, in blocks of 4, to receive either sotagliflozin or placebo for a period of 6 months. The primary outcome is changes in left ventricular mass by cardiac magnetic resonance from randomization to end of the study between the groups. Secondary end points include changes in peak VO2; myocardial mechanics, interstitial myocardial fibrosis, and volume of epicardial adipose tissue; distance in the 6-min walk test; and quality of life. Finally, the authors expect that this trial will help to clarify the potential benefits of the use of sotagliflozin in non-diabetic HFpEF patients.

Rationale and Design of the EMPA-TROPISM Trial (ATRU-4): Are the "Cardiac Benefits" of Empagliflozin Independent of its Hypoglycemic Activity?

The SGLT2 inhibitor empagliflozin reduced cardiovascular mortality by 38% and heart failure (HF) hospitalizations by 35% in diabetic patients. We have recently demonstrated the efficacy of empagliflozin in ameliorating HF and improving cardiac function in a non-diabetic porcine model of HF mediated via a switch in myocardial metabolism that enhances cardiac energetics. Therefore, we hypothesized that the cardiac benefits of empagliflozin can also be extended to non-diabetic HF patients. The EMPA-TROPISM clinical trial is a randomized, double-blind, parallel group, placebo-controlled, trial comparing the efficacy of and safety of empagliflozin in non-diabetic HF patients. Eighty patients with stable HF for over 3 months, LVEF < 50%, and New York Heart Association functional class II to IV symptoms will be randomized to empagliflozin 10 mg for 6 months or placebo. All patients will undergo cardiac magnetic resonance (CMR), cardiopulmonary exercise test (CPET), 6-min walk test, and quality of life questionnaires. The primary outcome is the change in left ventricular end-diastolic volume measured by CMR. Secondary end-points include change in peak VO2 (CPET); change in LV mass, in LVEF, in myocardial mechanics (strains), in left atrium volumes, in RV function and volumes, in interstitial myocardial fibrosis, and in epicardial adipose tissue (CMR); change in the distance in the 6-min walk test; and changes in quality of life (Kansas Cardiomyopathy questionnaire [KCCQ-12] and the 36-Item Short Form Survey [SF-36]). Safety issues (e.g., hypoglycemia, urinary infections, ketoacidosis,…) will also be monitored. In summary, EMPA-TROPISM clinical trial will determine whether the SGLT2 inhibitor empagliflozin improves cardiac function and heart failure parameters in non-diabetic HF patients (EMPA-TROPISM [ATRU-4]: Are the "cardiac benefits" of Empagliflozin independent of its hypoglycemic activity; NCT 03485222).

Do ACE inhibitors all provide the same outcomes benefits in high-risk cardiovascular patients?

The Heart Outcomes Prevention (HOPE) trial was the first to demonstrate the benefits of the angiotensin-converting enzyme (ACE) inhibitor ramipril for high-risk cardiovascular patients. Whether the cardioprotective effects seen in HOPE and other trials are specific to distinct ACE inhibitors remains controversial. Evidence of a lack of class effect for ACE inhibitors has policy and financial implications related to reference pricing by insurers and inclusion on pharmacy formularies. Because head-to-head trials comparing the different ACE inhibitors are unforeseen, clinicians and administrators must rely on secondary-level data and observational studies. Only a handful of studies have sought to address the dispute over a class effect among ACE inhibitors, which is reviewed in this article.