Applying a Holistic Digital Endpoint Strategy in the Development of Congestive Heart Failure Treatments

Biotech, Clinical Trials, Drug Discovery & Development, Life Science, Pharma,
  • Tuesday, September 16, 2025 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

As the treatment modalities, scope and complexity of clinical trials for congestive heart failure (CHF) drug development increase, so does the need for precision and accuracy in endpoint definitions and assessments. This webinar will provide a comprehensive exploration of how to integrate cardiac imaging, ECG and arrhythmia assessments, along with a meaningful patient report outcome strategy to optimize study outcomes, ensure data integrity and support regulatory success.

Attendees will gain an in-depth understanding of advanced cardiac monitoring techniques, including continuous arrhythmia assessment, blood pressure tracking and the use of 12-lead ECG to characterize cardiac function. The session will also examine recent professional guidelines and trends regarding patient-reported outcomes in heart failure trials and how these can help us to assess and understand symptom burden and quality of life more accurately.

Experts will present the limitations of relying on site-based echocardiography and discuss the advantages of blinded central review. Advanced modalities such as 3D echocardiography and cardiac MRI will also be reviewed. Finally, the discussion will address the critical role of independent clinical adjudication in major adverse cardiovascular events (MACE) studies, underscoring its value in achieving unbiased, regulator-grade endpoint classification.

This webinar is designed to equip clinical development teams with the scientific rationale and operational insights necessary to elevate the quality and impact of CHF clinical trials.

Register for this webinar to learn how a digital endpoint strategy can enhance data quality, support regulatory success and improve outcomes in heart failure trials.

Speakers

Vic Patel, Clario

Vic Patel, MD, PhD, VP & Chief Medical Officer, Cardiology, Clario

Dr. Vic Patel is board-certified in cardiology with a PhD in Biophysics and has done extensive research on mechanisms of cardiac arrhythmias. He was a faculty member at the University of Pennsylvania School of Medicine for 11 years, where he directed molecular arrhythmia research and practiced clinical electrophysiology. Dr. Patel then moved into drug development and cardiac safety as a Clinical Development Leader and Therapy Area Head across all phases.

At Clario, Dr. Patel oversees cardiology science and research, the consulting and ECG/Holter core lab services and he also leads the biostatistics and medical writing groups. He works with our global customers to ensure their needs are met with robust, cost-effective solutions.

Message Presenter
Dr. Thomas Moll, Clario

Thomas Moll, PhD, MBA, Senior Scientific Advisor, Clario

Dr. Thomas Moll has been working in the life sciences industry for more than 20 years and has held various positions both in the CRO space and within big pharma (Eli Lilly). Over the years, one of his areas of focus has been post-marketing projects that require patient experience data for regulatory decision-making, whether as a regulatory writer or coordinating large global Phase IV studies. Since joining Clario as a Scientific Advisor eCOA in 2022, he has participated in numerous new initiatives aimed at strengthening the role of science throughout the eCOA lifecycle to improve data integrity and ultimately patients’ benefit. In addition, he’s passionate about sharing his knowledge about the exciting world of drug development to young professionals.

Message Presenter
Judith Narisi, Clario

Judith Narisi, BSN, RN, Senior Medical Scientific Affairs Associate, Clario

Judy Narisi is a seasoned healthcare professional with over two decades of experience in clinical research. Trained as a critical care RN, Judy’s research journey began in 2004 as a Study Coordinator, progressing to safety event case management and ultimately event adjudication in 2006. She has held key roles at PharmaNet, Johnson & Johnson and ICON, where her team reviewed 9,000+ cases for a large CV outcomes trial in patients with type II diabetes at high CV risk that compared liraglutide with placebo using a primary composite endpoint of three-point major adverse CV events.

Judy began her tenure at Clario as a Senior Director of Adjudication Services and currently serves as a Senior Medical Affairs Associate for Adjudication. She has successfully managed a team that has been effective in rescuing several large programs and contributed to the approval of several pharmaceutical drugs supported by the adjudication of thousands of events. Judy received her nursing degree from Gwynedd Mercy University in Pennsylvania.

Message Presenter
Tonya Varcelli, Clario

Tonya Varcelli, PhD, Director, Scientific and Medical Affairs, CV Imaging, Clario

Dr. Tonya Varcelli has 20+ years of experience as a subject matter expert supporting clients to ensure comprehensive delivery of services for clinical trials. In her current role, she provides medical and scientific support to Clario study teams and departments to identify new tools and services that improve and expand Cardiovascular Imaging services for clients. She was previously an Imaging Research Scientist responsible for research and development of scientific imaging-related documentation for 80+ clinical trials, including Phase II-IV and pilot studies involving medical devices, pharmaceuticals and combination products (biologics). Tonya began her career as a PhD candidate at the Cleveland Clinic, followed by a role as a Clinical Trial Manager focusing on imaging components within Phase II-IV trials. She earned her PhD from Case Western Reserve University, where she also earned her Master of Science and Bachelor of Engineering, Summa Cum Laude.

Message Presenter

Who Should Attend?

This webinar will appeal to Clinical Trial Professionals in the following fields or having the following titles:

  • CEOs/Chief Medical Officers/Chief Scientific Officers
  • Clinical Data Managers/Clinical IT/Clinical Monitoring
  • Clinical Operations/Clinical Development
  • Clinical Research/Clinical Pharmacologists/Clinical Scientists
  • Data Science/Health Economics and Outcomes Research
  • Imaging Scientists/Medical Affairs/Medical Monitor/Head of Development for Program
  • PK Experts/Protocol Managers/Regulatory Affairs
  • Sr. Managers, Trial Initiation

What You Will Learn

Attendees will:

  • Gain a holistic understanding of how to align cardiac imaging and ECG assessments, along with PRO strategies to support robust endpoint definitions and regulatory success in congestive heart failure trials
  • Understand the importance of continuous arrhythmia monitoring, blood pressure tracking and the role of 12-lead ECG in evaluating cardiac function and safety in CHF trials
  • Explore the implications of the AHA’s April guidance on PROs in CHF studies, and how today’s trials are integrating these patient-reported outcomes to capture symptom burden and quality of life better
  • Learn why reliance on site-based echocardiography may compromise data quality, and how advanced modalities like centralized 3D echo and cardiac MRI can provide additional meaningful data beyond more standard approaches
  • Discover the essential role of independent clinical adjudication in MACE studies, ensuring unbiased, high-integrity endpoint classification

Xtalks Partner

Clario

Clario is a leading provider of endpoint data solutions to the clinical trials industry, generating high-quality clinical evidence for life sciences companies. We offer comprehensive evidence-generation solutions that combine medical imaging, eCOA, precision motion, cardiac and respiratory endpoints.

For more than 50 years, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have been deployed over 30,000 times to support clinical trials in more than 100 countries. Our global team of science, technology, and operational experts have supported over 70% of all FDA drug approvals since 2012.

For more information, go to Clario.com or follow us on LinkedIn.

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