JACC Heart Failure Editor's Update, November 2019
Dear Friends and Colleagues,
We are excited to present this issue dedicated to developing new therapies for heart failure, including a focus on wearables, a sham trial in mitral regurgitation, novel therapies and outcomes for cardiac amyloidosis, race and sex representation in HF trials, and publication of a “lean” case report form to standardize data collection in clinical trials.
Is the p value the only way to interpret the results of clinical research? In this month’s Editor’s Page, I provide a different perspective on the meaning of significance.
Christopher O'Connor, MD, MACC | @coconnormd
JACC: Heart Failure Editor-in-Chief
jacchf@acc.org
November 2019 JACC: Heart Failure—Focus Issue: Developing Therapies in Heart Failure: A New Era for Drugs and Devices
Standardizing and minimizing data collection in clinical trials will lead to efficiency in developing new HF therapies. Through collaboration with multiple stakeholders, including the FDA, a core, lean case report form (CRF) was developed for both drug and device trials. HF clinical trials are currently burdensome and inefficient, and sponsors collect the same variables in a number of different ways. The Heart Failure Collaboratory created a consortium to review and evaluate data elements routinely collected and create a “lean” core CRF consisting of fewer data items, establish a core set of variables with standard collection, and identify modular add-ons as required. This aims to minimize the core set of data elements collected and standardize collection to allow comparisons across trials.
Design of a "Lean" Case Report Form for Heart Failure Therapeutic Development
Mitchell A. Psotka, William T. Abraham, et al.
What is the current state of "wearables," and how will they affect heart failure care in the future? Wearable devices paired with technology to transmit and analyze data allow assessment and monitoring of care beyond the hospital and clinic, but interpreting these data and incorporating the results into clinical practice is challenging. The current status and potential applications of this important technology are examined by Dr. Adam DeVore and colleagues.
The Future of Wearables in Heart Failure Patients
Adam D. DeVore, Adrian F. Hernandez, et al.
Does treatment with ARNI have an early positive impact on health-related quality of life for HFrEF patients? New insights from CHAMP-HF (Change the Management of People with Heart Failure). The superiority of sacubitril/valsartan for the management of HFrEF patients was established in PARADIGM-HF, and health status at 8 months showed less deterioration, but the trial design did not incorporate short-term assessment of health status. Yevgeniy Khariton, et al examined data from the CHAMP-HF registry to determine if those treated with ARNI had a clinically meaningful improvement in KCCQ score in the early months following treatment.
Association Between Sacubitril/Valsartan Initiation and Health Status Outcomes in Heart Failure With Reduced Ejection Fraction
Yevgeniy Khariton, John A. Spertus, et al.
Percutaneous mitral annuloplasty to reduce functional mitral regurgitation (FMR) in HFrEF patients is examined in the REDUCE-FMR trial. This proof-of-concept study evaluated the effects of the Carillon Contour system on FMR severity and LV remodeling and is an important early step to large scale trials to determine the efficacy of this relatively safe and simple procedure.
The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation
Klaus K. Witte, Horst Sievert, et al.
Heart Failure Hall of Fame—Getting to Know the Pioneers Who Inspire Us
Our Heart Failure Hall of Fame series brings information about leaders in the field of heart failure beyond their publications and extensive work. This month we feature Dr. Maria Rosa Costanzo. Dr. Costanzo is Medical Director for Heart Failure Research at the Advocate Heart Institute. She serves on the ABIM Advanced Heart Failure and Transplant Cardiology Exam Writing Committee, and she is on the HFSA Board of Directors and was a founding member of the society. She has led several multicenter randomized clinical trials; has written more than 200 papers published in top tier journals; presents nationally and internationally on numerous topics related to heart failure and cardiac transplantation; and is on the editorial board for Journal of the American College of Cardiology, Circulation Research, the New England Journal of Medicine, the Journal of Cardiac Failure, JACC: Heart Failure, Circulation Heart Failure, the European Heart Journal, the European Journal of Heart Failure, and the International Journal of Cardiology. She has been an elite reviewer for our journal and always provides exceptional insight as a peer reviewer and editorialist.
What first made you interested in a career in heart failure?
I had the fortune of being invited as a researcher at the University of Wisconsin, Madison, in the laboratory of Dr. Fritz Bach, a pioneer of histocompatibility. This led to my passion for heart transplantation. I quickly understood that the lifeline of a successful heart transplant program was the establishment of a large heart failure program. The more heart failure patients I treated, the more intrigued and enthusiastic I became for every aspect of the syndrome, from its pathophysiology to innovative treatments.
Which of your many accomplishments are you most proud of?
Having served as the Editor in Chief of the Journal of Heart and Lung Transplantation.
Having maintained my intellectual curiosity and passion for research regardless of whether my work environment is academic or private practice.
Who inspires you, in your career or otherwise?
My husband Louis, because of his unbending integrity, boundless generosity, self-confidence without arrogance, and unconditional support of my personal and professional endeavors.
What is your favorite, or last book you read?
My favorite book is the Divine Comedy by Dante Alighieri. Although written almost 1000 years ago, it has unsurpassed insights into the noblest and vilest human attributes, an understanding that remains highly relevant today.
Among more recent books, my favorite is Team of Rivals by Doris Kearns Goodwin, because it vividly explains how Abraham Lincoln was able to harness opposing views to effectively steer the country in the morally right direction.
3 Things People May Not Know About Me
- I graduated from the University of Bologna, the oldest medical school in recorded history, having been founded in 1088 C.E.
- I have traveled to Africa almost 30 times because I love the people, the diverse cultures, the amazing art, and the wildlife. In Africa, I have a sense of belonging that I do not experience anywhere else in the world.
- After medicine, my greatest passion is photography because it gives me a unique perspective on people, landscapes, and living creatures. Through photography, I can also express the creative/artistic side of my personality.
Learn More about Dr. Costanzo
Dr. Maria Rosa Costanzo received her medical degree summa cum laude from the University of Bologna in Italy. Her postgraduate training included a fellowship in cardiology at Loyola University Medical Center in Maywood, Illinois. Dr. Costanzo is a Fellow of the American College of Cardiology, American Heart Association, and European Society of Cardiology. She is also a member of the Ordine Dei Medici (The Italian National Medical Professional Association).
Dr. Costanzo served as Medical Director of the Loyola University Chicago Heart Failure and Cardiac Transplant Program from 1988 until 1994. From 1994 until 2001, she was the Medical Director of the Heart Failure/Cardiac Transplant Program at Rush University Medical Center and was the John H. and Margaret V. Krehbiel Professor of Cardiology at the Rush Medical College. From 1995 until 2000, Dr. Costanzo was the Editor in Chief of the Journal of Heart and Lung Transplantation.
In 2002, Dr. Costanzo became the Medical Director of the Edward Center for Advanced Heart Failure. She was also appointed by the Secretary of Health and Human Services, the Honorable Tommy Thompson, to serve a four-year term on the National Heart, Lung and Blood Institute Advisory Council.
She has been a member of the American Board of Internal Medicine exam writing committee for the specialty of Advanced Heart Failure and Transplant Cardiology since 2012 and is currently a member of the Board of Directors of the Heart Failure Society of America.
Dr. Costanzo has led several multicenter randomized clinical trials including UNLOAD, AVOID-HF and the Pivotal Trial of phrenic nerve stimulation for central sleep apnea. She has written more than 200 papers, abstracts, and articles for journals such as New England Journal of Medicine, Circulation, Journal of the American College of Cardiology, JACC: Heart Failure, Circulation Heart Failure, and the European Journal of Heart Failure. She has presented nationally and internationally on numerous topics related to heart failure and cardiac transplantation, and is also a consultant for several publications, including the Journal of the American College of Cardiology, Circulation Research, the New England Journal of Medicine, the Journal of Cardiac Failure, JACC: Heart Failure, Circulation Heart Failure, the European Heart Journal, the European Journal of Heart Failure, and the International Journal of Cardiology.
She is currently the Medical Director for Heart Failure Research at the Advocate Heart Institute.