Cardio Pod: Heart of the Matter

In this episode, host Christopher O’Connor and his colleagues discuss device trials and how they differ from drug trials. The conversation focuses on how device trials can be improved and how to advance device development overall.

Host Christopher O’Connor, MD is joined by Jana Svetlichnaya, MD; Anu Lala-Trindade, MD; and Marshall Brinkley, MD to unpack the challenges of site-based research.This episode dives into the barriers, obstacles, and opportunities investigators face—and what it truly takes to build and sustain a successful research site.

This episode explores two different ways of analyzing outcomes in clinical trial and longitudinal studies in cardiovascular and heart failure research.

In this episode, host Dr. Christopher O'Connor sits down with Dr. Robert Califf, MD, Nicholaas Honig, JD, Dr. Maria Rosa Costanzo, and Dr. Norman Stockbridge, MD, PhD to explore the role of real-world evidence in advancing therapeutic development and improving patient outcomes.

In this episode, Christopher O’Connor, MD, sits down with Melvin Echols, MD; JoAnn Lindenfeld, MD; Minnow Walsh, MD; and Wayne Batchelor, MD to explore the role of social drivers of health in heart failure clinical trials.This discussion stems from an initiative of the Heart Failure Collaboratory (HFC) that led to a publication in JACC: Heart Failure titled “Social Drivers of Health in Heart Failure Trials: An Analysis from the Heart Failure Collaboratory.

This episode discusses further the challenges of site-based research. What goes into those barriers, obstacles, and opportunities to be a successful site-based researcher.

In this episode, Host Dr. Christopher O’Connor is joined by Dr. Melvin Echols, Dr. Anu Lala-Trindade, Dr. Maria Rosa Costanzo, Dr. Lars Kober, and Dr. Norman Stockbridge to explore key models of success in site-based research. The discussion covers operational efficiency, dedicated research infrastructure, sustainable funding and business models, collaborative partnerships, diversity and patient access, and excellence in quality and compliance.

Hosted by Christopher O’Connor, MD, this episode dives into why site-based research is “broken” — fragmented, inefficient, and weighed down by administrative and regulatory burdens.Many clinical research sites — especially community hospitals and smaller practices — face inconsistent funding, delayed contract approvals, and limited infrastructure for study coordination and data management.Join Dr. O’Connor and expert guests Melvin Echols, MD; Anu Lala-Trindade, MD; Maria Rosa Costanzo, MD; Dalane Kitzman, MD, Marat Fudim, MD; and Sumeet Mitter, MD as they unpack the systemic challenges and explore how to create a more efficient, equitable research ecosystem.#HeartFailureCollaboratory #ClinicalResearch #heartfailure

In this episode, host Dr. Christopher O’Connor is joined by Dr. Christian Guilliod, Dr. Wayne Batchelor, Dr. Mona Fiuzat, and Dr. Orly Vardeny to discuss the need for clinical trials to reflect the populations most affected by disease, emphasizing culturally and demographically aligned recruitment. They advocate for targeted, site-based strategies and raise concerns about interpreting results from unrepresentative samples.

In this episode, Host Christopher O’Connor, MD, is joined by Robert Califf, MD; Michael Bristow, MD; Scott Solomon, MD; Marvin Konstam, MD; and Mona Fiuzat, PharmD, to discuss who should have access to clinical trial data amid growing collaboration between academia and industry. The conversation highlights the importance of transparency, trust, and responsible data interpretation to maintain scientific integrity.

In this episode, experts Jonathan Cunningham, MD; Ankeet Bhatt, MD; Trejeeve Martyn, MD; Anu Lala-Trindade, MD; Sneha Shah Jain, MD; Elise Shalowitz, MS; and Mitchell Psotka, MD join host Christopher O’Connor, MD to explore AI’s role in transforming clinical trials by reducing workload, improving recruitment, and enhancing protocols. Together, they discuss AI’s use in clinical workflows, continuous evaluation, and inclusive recruitment, stressing the need for healthcare support to maximize success.

Only with cardiology with nephrology working together can the field of acute decompensated heart failure move forward with respect to kidney related entry criteria & endpoints. We call for standardization to allow for real progress. Host Chris O'Connor invites authors of the HFC, newly published JACC Expert Panel, Anuradha Lala, Maria Rosa Costanzo, Muthu Vaduganathan, Jason Feinman, Mona Fiuzat, and Steven Coca to discuss this HF-ARC initiative.

How can artificial intelligence enhance and augment clinical trials? In what ways can it be used responsibly to increase trial efficiency? Host Chris O'Connor invites Martin Cowie, JoAnn Lindenfeld, Scott Solomon, Jon Cunningham, Mona Fiuzat, and Mitch Psotka to discuss the role of AI in clinical trials.

Host Dr. Christopher O'Connor invites Drs. Scott Solomon, William Abraham, JoAnn Lindenfeld, Brian Claggett, Mona Fiuzat, and Mitchell Psotka to continue discussion of the importance of subgroups in heart failure clinical trials. How can we analyze subgroups and determine the differences between subgroups and special populations?

Host Dr. Christopher O'Connor invites Drs. Javed Butler, Mariell Jessup, and Mitchell Psotka to discuss the importance of subgroups in heart failure clinical trials. How do we appropriately define subgroups? Which groups should be included as standard practice in HF trials?

Dr. Christopher O'Connor interviews the founding members of the data safety monitoring board (DSMB) training team, Dr. David DeMets, Dr. Janet Wittes, and Dr. Thomas Flemming, to continue discussing the importance of training the next generation in clinical trial leadership. Using their extensive experience in clinical trials, they address which practices will best serve future members, and the critical shortage of trained experts.

Drs. Janet Wittes, Mona Fiuzat, Maria Rosa Costanzo, Ana Barac, Barry Greenberg, Vanessa Blumer, and Michael Bristow come together on this episode with Dr. Christopher O'Connor to discuss initiatives to train the next generation of DSMB members. How do we pass on the experience and knowledge of seasoned DSMB members and properly train the next generation?

Drs. Mariell Jessup, JoAnn Lindenfeld, Maria Rosa Costanzo, Mona Fiuzat, Bill Abraham, and Wayne Batchelor join Christopher O'Connor to discuss the recruitment of women in HF clinical trials. What has been done so far and where do we go from here?

Drs. Peter Carson, JoAnn Lindenfeld, John Teerlink, Orly Vardeny, and Bill Abraham join Dr. Christopher O'Connor to discuss the implications of the FDA Advisory Committee meetings with special focus on three programs: TOPCAT (2:05), PARAGON-HF (15:53), and GALACTIC-HF (30:35).

Special guests Melvin Echols, Nasrien Ibrahim, Vanessa Blumer, Wayne Batchelor, JoAnn Lindenfeld, and Mitchell Psotka join the podcast to discuss the importance of enrolling diverse populations in HF clinical trials. How can we target a more representative population?

James Januzzi, Maria Rosa Costanzo, John Teerlink, Marv Konstam, Bill Abraham, and nephrologist Steven Coca join the podcast to discuss HF and AKI. How should we react to rising creatinine?

Janet Wittes, Eric Leifer, Bill Abraham, and Mitchell Psotka join the podcast to discuss all-things statistics. What is an estimand? How should we treat p-values?

Expert statisticians Janet Wittes and Eric Leifer join the podcast to discuss hazard ratios, the phenomenon of "hazard ratio drift", and other contemporary challenges in HF clinical trial design.

Join Drs. Christopher O'Connor, JoAnn Lindenfeld, Mitchell Psotka, Scott Solomon, Mona Fiuzat, Bill Abraham, and Peter Carson as they introduce a novel concept known as the Heart Failure Collaboratory (HFC) and discuss how it can contribute to the field of heart failure research.