Introduction to Cardiovascular Trials

This paper provides an overview on different types of adaptive designs in clinical trials and their applications to cardiovascular trials.

FACT (French Alliance for Cardiovascular Trials), DHUFIRE, Hopital BichatClaude Bernard, Paris, France Université de Paris, Assistance Publique—Hôpitaux de Paris, Paris, France.

We review the existing web-based tools including Sheffield Accelerated Value of Information (SAVI), the web interface to the BCEA (Bayesian Cost-Effectiveness Analysis) R package (BCEAweb), Rapid Assessment of Need for Evidence (RANE), and Value of Information for Cardiovascular Trials and Other Comparative Research (VICTOR).

Long-term cardiovascular trials are currently ongoing to establish the cardiovascular safety of tirzepatide.

3 In addition to enhancing diversity of healthcare practitioners and clinical research staff, potential strategies that have been identified to begin addressing the prolonged underrepresentation of non-White individuals in cardiovascular trials include creating an inclusive implementation checklist that involves building meaningful trust, ensuring participant safety, highlighting available support, providing clear information for patient-centered shared decision making, addressing individuals’ perceived constraints, and leveraging a multiple stakeholder approach to communicate a common goal.

Specific cardiovascular trials are re-analysed with Bayesian methods.

Given the complex interplay between cardiac and kidney disease and the possibility that treatments may show concordant cardio-kidney benefits, there has been recent interest in formally acknowledging, defining, and using composite cardio-kidney outcomes in future cardiovascular trials.

Using examples from cardiovascular trials, this article describes a potential path forward with a focus on applications in the United States.

Figures from the British Heart Foundation found that cardiac surgeries or interventions were down by 27%; and in the USA, evidence emerged of a deterioration in cardiovascular risk factor control, along with ‘a marked disruption’ of cardiovascular trials.

Background Cardio/kidney composite end points are clinically relevant but rarely analyzed in cardiovascular trials.

However, the extent to which cardiovascular trials incorporate evidence-based recruitment strategies in their protocols is understudied.

BACKGROUND An endpoint that has received some attention in recent cardiovascular trials is 'days alive and out of hospital' (DAOH).

Women are under-represented as leaders of cardiovascular randomized controlled trials, representing 1 in 10 lead authors of cardiovascular trials published in high-impact journals.

Cardiac fibrosis not only accelerates the deterioration progress of diseases but also becomes a pivotal contributor for futile treatment in clinical cardiovascular trials.

The lower representation of women may have been influenced by two large cardiovascular trials that included 75% men.

However, several systematic reviews of cardiovascular trials have observed that patients with kidney disease, particularly those with advanced kidney disease, are often excluded from trial participation.

Among cardiovascular trials, we set out to systematically compare the incidence of cardiovascular events and estimated randomized treatment effects ascertained from RHD versus traditional clinical evaluation and adjudication.

Background: Sex-based differences are under-studied in cardiovascular trials as women are commonly underrepresented in dual sex studies, even though major sex-based differences in epidemiology, pathophysiology, and outcomes of cardiovascular disease have been reported.

BACKGROUND Globalization of cardiovascular trials increases generalizability.

Cohort selection for future cardiovascular trials with allopurinol is crucial.

Large, simple, cardiovascular trials have successfully discovered treatments with moderate but worthwhile effects to prevent heart attack and stroke.

Since 2006, the Academic Research Consortium (ARC) group has taken the lead in gathering major stakeholders, such as the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI), the Universal Definition of Myocardial Infarction (UDMI), and the Society for Cardiovascular Angiography and Interventions (SCAI), in order to agree on common definitions.

We sought to assess the trend of minority and female representation across cardiovascular trials.

The exclusion of chronic kidney disease (CKD) patients from clinical trials-particularly cardiovascular trials-remains a long-standing, unsolved problem, which prevents the optimization of clinical care in these patients.

CONCLUSIONS Considerable variations in FI were observed among cardiovascular trials, suggesting the need for careful interpretation of results, particularly when number of patients lost to follow-up exceeds FI.

Key Points Question Do null results on cognitive function in cardiovascular trials exclude worthwhile benefit? Findings In this secondary analysis of 3 randomized clinical trials including 45 029 participants undergoing cognitive assessment, the prevention of nonfatal cardiovascular events in 4.

In cardiovascular trials of inhibitors of sodium-glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes.

Non-inferiority cardiovascular trials with a surrogate primary endpoint present particular challenges in clinical interpretation.

We sought to characterize non-inferiority cardiovascular trials published in the highest-impact journals, features that may bias results toward non-inferiority, features related to reporting of non-inferiority trials, and the time trends.

In cardiovascular trials, effects on incidence of cancer metastases.

The importance of finding effective strategies to limit this self-exclusion phenomenon, especially in cardiovascular trials, is strongly supported by the following evidence: (a) depression and cardiovascular diseases are actually two of the most common diseases in industrialised areas; (b) they often appear in comorbidity; and (c) cardiac patients are 3–4 more times at risk of developing depressive and anxiety disorders compared to the general population.

We discuss some of these issues using historical experience with primary prevention cardiovascular trials and then focus on unique issues surrounding patient populations at risk for rheumatoid arthritis.

We sought to characterize noninferiority cardiovascular trials publi.

Randomized cardiovascular trials aimed to reduce the excessive residual risk in high‐risk patients through a more aggressive low‐density lipoprotein‐cholesterol control or targeting triglycerides or high‐density lipoprotein‐cholesterol levels have shown a null or, at best, limited incremental benefit.

Differences in pathophysiology, clinical presentation, and outcomes of cardiovascular disease in men and women have been known for decades, but are not fully understood; women are underrepresented in most cardiovascular trials.