Hospital admissions for almost everything came to almost a complete halt this year because of the pandemic. In March and April 2020, people stopped coming…
James Stein Interview with SAMSON senior author Darrel Francis: Statin Side Effects – The Symptoms are Real
The SAMSON trial recruited patients who had given up statins for good due to side effects. Why was the trial needed and what do the…
SAMSON and the Future of Clinical Trials in Cardiology
The most interesting and impactful trial presented at the AHA this week (and simultaneously published in the New England Journal of Medicine) was the SAMSON trial,…
COVID-19 Heart: We have all the gear but no idea
We have plenty of sophisticated gear to understand heart problems. For COVID-19, we’ve seen Troponin blood tests, cardiac MRIs and echo. For example, cardiac injury was associated with a higher risk of death in hospitalized patients. And yet, we have no answers to the questions that matter for clinical practice.
Darrel Francis Interview with Matthew Budoff: Demistifying the EVAPORATE trial of icosapent ethyl
Darrel Francis speaks to Matthew Budoff about EVAPORATE trial and asks about the plaque progression in the placebo arm and the choice of placebo. EVAPORATE was a follow-on mechanistic study from REDUCE-IT and was presented at the European Society of Cardiology 2020 and published in the European Heart Journal.
Under-Representation of Women in Heart Failure Trial Leadership
Women have been under-represented as professionals in cardiology and as researchers. In a systematic review of randomized clinical trials published in high impact journals, we…
CVCT Global Forum Preview: One Patient Does Not Engagement Make
What is “patient engagement”? What does that really mean, and how can we ensure that patients are given opportunities to provide meaningful input into clinical trials?
Missed MI in the emergency department and early stress testing
People with chest pain go to the Emergency Department (ED). They get checked out. Some get diagnosed with acute coronary syndrome. Some get diagnosed with other conditions. And some get told there is nothing wrong.
New drugs for Heart Failure: “My cup runneth over”
The therapy of patients with Heart Failure with reduced ejection fraction (HFrEF) has evolved over the past several decades. Beta blockers; ACEIs, ARBs or sacubutril/valsartan; along with a MRA; a loop diuretic; and hydralazine/ISDN (in African Americans) form the basis of current guideline recommended therapy. Despite their use, even when appropriately dosed at target levels, there remains a considerable incidence of hospitalizations for Heart Failure (HHF) and cardiovascular mortality (CVM) as well as compromised quality of life and increased health care costs.
Data Safety Monitoring Boards for Dummies
To get my children to finish their broccoli, I tell them that I experiment on people. That is not far from the truth, as I design and run clinical trials for a pharmaceutical company. To develop new medicines, we need to understand how they work and how they may cause trouble. There are many steps in this process, the last of which is testing these medicines in people as part of a clinical trial. This is not an entirely benign proposition for potential subjects. More often than not, new medicines tested in clinical trials are not effective in treating the disease. Worse yet, they may not be sufficiently safe compared to currently approved medicines—if any.