Clinical Trials Commons^™

Defining Clinically Meaningful Within-Patient Changes In Heart Failure: Jacc Heart Failure Position Statement, Amin Yehya, Rebecca Hahn, Barry Borlaug, Victoria Delgado, Andrew Ambrosy, Ross Arena, Nosheen Reza, Gregory Lewis, Natalie Tapaskar, Salvatore Carbone, Cynthia Chauhan, Mitchell A. Psotka, Norman Stockbridge, James Januzzi, Javed Butler, Jennifer Cowger, Biykem Bozkurt, John Spertus

Department of Medicine Faculty Publications

Heart failure (HF) clinical trials increasingly rely on diverse endpoints beyond mortality, including hospitalizations, imaging, hemodynamic status, biomarkers, functional capacity, and patient-reported outcomes. Although statistically significant differences between treatment groups are commonly reported, interpreting whether these changes are clinically meaningful for individual patients remains challenging. This JACC: Heart Failure position statement proposes a pragmatic framework for defining clinically meaningful within-patient change across commonly used HF outcomes by integrating measurement variability, prognostic associations, and patient-anchored evidence where available. Relative and absolute risk reductions should both inform interpretation of clinical events, while imaging, hemodynamic, biomarker, and functional measures require changes exceeding measurement …

Nirmatrelvir-Ritonavir Targeting Viral Persistence In Post-Covid-19 Condition (Long Covid) In The Usa (Recover-Vital): A Randomized, Double-Blind, Placebo Controlled, Phase 2 Trial, Lindsey R. Baden, Nirav S. Shah, Sean T. H. Liu, Jonathan Cohen, James May, Andre Kumar, Grace A. Mccomsey, Peter Chen, Michelle Floris-Moore, Nora G. Singer, Inti Fernandez, Alex J. Slandzicki, Zanthia Wiley, Alexandra Kadl, David A. Kaminsky, Harvey Hsu, Tiffany A. Walker, Aluko A. Hope, Luis Ostrosky-Zeichner, Jason D. Goldman, Michael J. Peluso, Thomas F. Patterson, Sairam Parthasarathy, Janet M. Mullington, Paul Bolin Jr., Sarah E. Jolley, Jerry A. Krishnan, Mario Castro, Sally L. Hodder, Priscilla Pemu, Helen Y. Chu, Michael G. Risbano, Maya R. Jerath, Eleftherios Mylonakis, Ryan T. Hurt, Radica Alicic, Nabila S. Azad, Marc A. Sala, Michelle S. Harkins, Jeffrey Parsonnet, Neil Stafford, Philip Robinson, Sabiha Hussain, Xian Qiao, Sophie Two Hawk, Michael Lillestol, Nathan Erdmann, Kelly A. Gebo, Praveen Sudhindra, Joseph Sassine, Gailen D. Marshall, Tulika Chatterjee, Caryn G. Morse, Eyal Kedar, William W. Stringer, Jennifer A. Frontera, Michael Jordon, Caitlin Blaskewicz, Jorge L. Santana, Rachel A. Foot, Cherry Wongtrakool, Matthew William Mccarthy, Alem Mehari, Arch Amon, Alison K. Cohen, Nita Jain, Christine Maughan, Doug Lindsay, Rachel Olson, Samuel Broderick, Pearl Rowe, Sean M. O'Brien, David R. Walt, Bruce D. Levy, Leonard A. Jason, Phillip A. Low, Cyndya A. Shibao, Barry Make, Lucinda Bateman, Susan Redline, David Knopman, Adrian F. Hernandez, Tracy L. Nolen, Craig Reist, Lisa Berdan, Richard Whitley, Kanecia O. Zimmerman, For The Recover-Vital Clinical Trial Group

Department of Medicine Faculty Publications

Background

Post-acute sequelae of SARS-CoV-2 infection, more commonly known as long COVID, has emerged as a major health problem. The pathogenesis of long COVID is unknown, but among the leading hypotheses is viral persistence. We aimed to investigate whether the use of the SARS-CoV-2 antiviral nirmatrelvir-ritonavir improved long COVID symptoms.

Methods

We conducted a double-blind, placebo-controlled, randomised trial involving adults who had developed persistent symptoms (≥12 weeks) associated with three major symptom phenotypes (cognitive, autonomic, or exercise) after acute SARS-CoV-2 infection at 69 US sites. Participants were eligible if they were 18 years or older and had a previous suspected, …