Publications

The HF Collaboratory white paper published in JACC titled Improving Heart Failure Therapeutics Development in the United States summarizes the discussions, challenges and opportunities, and makes recommendations to achieve improved efficiency in clinical trials and the development of effective heart failure therapies, including the formation of an organized Heart Failure Collaboratory.

J Am Coll Cardiol. 2018 Jan 30;71(4):443-453. doi: 10.1016/j.jacc.2017.11.048.

Dr O’Connor & Dr Bristow’s article on Changing the Research Culture in the United States further highlights the importance of what changes the HF Collaboratory are working towards.

JACC Heart Fail. 2018 Apr;6(4):344-345. doi: 10.1016/j.jchf.2018.03.001.

The article published in JAMA Cardiology titled Enrollment of Older Patients, Women, and Racial and Ethnic Minorities in Contemporary Heart Failure Clinical Trials discusses the under representation of these groups in clinical trials.

JAMA Cardiol. 2018 Oct 1;3(10):1011-1019. doi: 10.1001/jamacardio.2018.2559.

The article published in JACC: Heart Failure online titled: Design of a “Lean” Case Report Form for Heart Failure Therapeutic Development 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. Supplemental materials: Lean CRF JACC HF Supplemental Files

JACC Heart Fail. 2019 Nov;7(11):913-921. doi: 10.1016/j.jchf.2019.07.001. Epub 2019 Aug 7.

The white paper published in Circulation titled: Heart Failure End Points in Cardiovascular Outcome Trials of Sodium Glucose Contransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitius: A Critical Evaluation of Clinical and Regulatory Issues summarizes the discussions and key takeaway messages from the meeting on this topic at the FDA meeting on March 6, 2019.

Circulation. 2019 Dec 17;140(25):2108-2118. doi: 10.1161/CIRCULATIONAHA.119.042155. Epub 2019 Dec 16.

Communications

Dear Friends and Colleagues,

The mission of the HFC has focused largely on clinical trials, and the impact of COVID-19 on clinical research will be significant. The FDA has issued the following guidance with suggestions and recommendations. We have offered to collect any questions not addressed in the guidance and pass them along on behalf of HFC members. We hope this will be helpful in answering the many questions we are all facing.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic

 

You may send questions to me directly via email and we will facilitate as much as we can on behalf of the HFC.

 

Kind regards,

 

Mona Fiuzat

Chris O’Connor

JoAnn Lindenfeld

Bill Abraham

Mitch Psotka

Bram Zuckerman

Norman Stockbridge

Heart Failure Collaboratory Co-Chairs and Members

NIH Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-087.html

The Heart Failure Collaboratory is proud to announce the winners of the HFC -HFSA Research Network Awards. In its inaugural year, this joint effort recognized individuals and sites in the following categories: Research Site, Principal Investigator and Site Coordinator. Below is a list of all awardees:

Pictured left to right:

Stephen Heitner, MD, Mitchell Psotka, MD, PhD, Chris O’Connor, MD, HFSA President 2017-2018, Randy Starling, MD, HFSA President 2018-2019, Biykem Bozkurt, MD, HFSA President 2019-2020, Palak Shah, MD

Pictured left to right:

Biykem Bozkurt, MD, HFSA President 2019-2020, Randy Starling, MD, HFSA President 2018-2019, Palak Shah, MD, Mitchell Psotka, MD, PhD, Venkatesh Nadar, MD, Anjali Owens, MD, Chris O’Connor, MD, HFSA President 2017-2018

Pictured left to right:

Biykem Bozkurt, MD, HFSA President 2019-2020, Randy Starling, MD, HFSA President 2018-2019, Amanda Radle, MS, Lydia McGowan, MS, CCRP, Chris O’Connor, MD, HFSA President 2017-2018