Publications

As a community of investigators, we have struggled to improve the recruitment of representative populations into heart failure (HF) trials.

The purpose of this study was to evaluate in-hospital outcomes among patients with a history of heart failure (HF) hospitalized with coronavirus disease-2019 (COVID-19).

The treatment of heart failure with reduced ejection fraction (HFrEF) has changed considerably over time, particularly with the sequential development of therapies aimed at antagonism of maladaptive biologic pathways. In an effort to provide a decision-making framework in the current era of expanding therapeutic options in HFrEF, the Heart Failure Collaboratory convened a multi-stakeholder group, including patients, clinicians, clinical investigators, the U.S. Food and Drug Administration, industry, and payers who met at the U.S. Food and Drug Administration campus on March 6, 2020. This paper summarizes the discussions and expert consensus recommendations.

Despite rigorous data supporting the benefits of optimal medical therapy (OMT) as recommended by the guidelines for patients with heart failure (HF) with reduced ejection fraction, the implementation and maximization of these therapies in the “real world” continues to be challenging.

Heart failure (HF) patients experience a high burden of symptoms and functional limitations, and morbidity and mortality remain high despite successful therapies.

As we continue to obstacles to the heart failure therapeutic development process through the work of the Heart Failure Collaboratory (HFC), the challenge of site-based research remains.

The coronavirus disease-2019 (COVID-19) pandemic has profoundly changed clinical care and research, including the conduct of clinical trials, and the clinical research ecosystem will need to adapt to this transformed environment.

The COVID-19 pandemic has disrupted health care delivery systems around the world, with a significant impact on clinical trials.

The study sought to demonstrate the statistical and utilitarian properties of restricted mean survival time (RMST) and restricted mean time lost (RMTL) for assessing treatments for heart failure (HF) with reduced ejection fraction.

A series of meetings were convened to establish definitions and key concepts for the evaluation of HF therapies.

Patient access to a drug after US regulator approval is controlled by complex interactions.

Gender disparities in authorship of heart failure (HF) guideline citations and clinical trials have not been examined.

Clinical trial inefficiency and lack of patient access to novel therapies have been identified as key barriers to successful heart failure innovation.

The white paper published in Circulation summarizes the discussions and key takeaway messages from the meeting on this topic at the FDA meeting on March 6, 2019.

The article published in JACC details the creation of a core CRF electronic form which is now freely available for use in clinical trials to improve clinical trial efficiency in HF drug and device development in the United States.

The article published in JAMA Cardiology discusses the under representation of these groups in clinical trials.

Dr O’Connor & Dr Bristow’s article further highlights the importance of what changes the HF Collaboratory are working towards.

Summarizes the discussions, challenges and opportunities, and makes recommendations to achieve improved efficiency in clinical trials and the development of effective heart failure therapies.