The Future of HFrEF Trials
Monday, December 7th: 1:30 – 3:30 pm
Therapy for heart failure with reduced ejection fraction (HFrEF) is constantly evolving. Despite the use of beta blockers, ACEIs, ARBs, sacubutril/valsartan, mineralocorticoid-receptor antagonists (MRA), and diuretics, HF continues to confer a substantial burden in terms of hospitalizations, CV mortality (CVM) as well as compromised quality of life and increased health care costs. The quest for more effective therapies for patients with HFrEF continues. Over the past several months, we have heard about 3 new therapies that may improve outcomes in patients with HFrEF, the SGLT2is, in particular dapagliflozin and empagliflozin, a nitric oxide stimulator, vericiguat, and, a cardiac myosin activator, omecamtiv mecarbil. Where do we go from here both in terms of optimizing HF therapy, and designing and conducting future clinical trials?
This session will be co-chaired by Dr. John Cleland, Director of the Robertson Centre for Biostatistics and Clinical Trials, at the University of Glasgow, GBR, and Dr. Milton Packer, the Distinguished Scholar in Cardiovascular Science from the Baylor University Medical Center in Dallas, TX, USA.
Should the new agents be added to guideline recommended treatment regimens? Should our patients routinely be on a minimum of 6 drugs? This session will focus on how to launch new trials in HFrEF in the current therapeutic environment. We will debate how to determine the minimum standard of care in the “placebo” arm of trials, and what other therapy is essential in the active treatment arm. It may be time to conduct more implementation strategy trials. More information is needed on which agents should be used in which order, and what patient and treatment factors should impact the sequencing of available treatments.
Should we consider starting all effective drugs early in therapy? Although we have a minimum of 6 classes of effective HF therapies, in truth patients are on many more therapies such as statin, and antiplatelet agents, as well as for multiple comorbid conditions, such as diabetes, kidney disease, arthritis, or many more. Compliance becomes an increasingly troubling issue as additional therapies are introduced. In hypertension there is evidence that optimal results are achieved with a single pill combination therapy. Should we be developing and advocating the use of fixed-dose combination therapies for HF?
Joining our co-chairs are cardiologists Javed Butler (Jackson, USA), and Bertram Pitt (Ann Arbor, USA). We will have broad industry representation during this session to bring us up-to-date on what the pharmaceutical companies are working on, and where they see drug trials going in the future. What do they see as some of the challenges, and barriers to conducting on-going and new trials? Speakers will include: Thomas Andersson (AstraZeneca, SWE), Martina Brueckmann (Boehringer, GER), Jyothis George (Novonordisk, DEN), Richard Nkulikiyinka (Bayer), Benoit Tyl (Servier, FRA), Salim Shah (Sarfez, USA), and Mahesh Patel (MSD, USA).
Stay tuned for the moderated multi-stake holders’ debate, which will include additional representatives from cardiologists, industry, and regulatory bodies. If you want to know the future of HF management join these panelist while they look into their crystal balls.