ACC 2025 Clinical Trials to Watch with Deepak Bhatt, MD, MPH, MBA

Few fields have experienced as much rapid advancement and transformation in recent years as cardiology. With groundbreaking insights into cardiovascular disease (CVD) mechanisms driving innovations in treatment, from novel lipid-lowering therapies to next-generation heart failure (HF) management and structural interventions, cardiologists must navigate a landscape of continuous breakthroughs that many specialties would equate to decades’ worth of progress.

These notable advancements in recent years continue to set the stage for the American College of Cardiology 74th Annual Scientific Session & Expo. This year’s meeting, taking place in Chicago from March 29-31, boats more than 4,750 accepted abstracts, with 1,300 expert faculty and 300 sessions, encompassing 53 late-breaking clinical trials.

A leading subject matter expert in cardiology, Deepak Bhatt, MD, MPH, MBA, director of the Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at Icahn School of Medicine at Mount Sinai, is among the meeting’s planned attendees and presenters at this year’s ACC congress. For more insight into his perspective on this year’s meeting, the editorial team of HCPLive Cardiology spoke with Bhatt to learn what trials he was most looking forward to in Chicago.

Check out a rundown of Bhatt’s top 3 picks and when they are scheduled to be presented in our list below:

Top 3 Trials to Watch at ACC 2025

The Effect Of Once-weekly Subcutaneous Semaglutide On Functional Capacity In People With Type 2 Diabetes (T2D) And Peripheral Artery Disease (PAD): Primary Results From The Phase 3b, Randomized, Placebo-controlled, Double-Blind Stride Trial

Presentation Time: Saturday, March 29, 2025, from 09:50-10:02 AM CT

Presenter: Marc Bonaca, MD

Description: STRIDE (NCT04560998) is a randomized, placebo-controlled, double-blind phase 3b trial evaluating 1 mg once-weekly subcutaneous semaglutide, a glucagon-like peptide 1 receptor agonist (GLP-1 RA) versus placebo, in people with symptomatic PAD (Fontaine IIa claudication) and T2D. Eligible participants were ≥18 years old, had hemodynamically stable PAD, had no planned intervention, and were not receiving a GLP-1 RA.

The primary endpoint is the change in maximum walking distance on a constant-load treadmill (CLT), with secondary endpoints including quality of life and cardiometabolic assessments. STRIDE will provide evidence on functional outcomes with semaglutide in people with PAD and T2D.

Oral Semaglutide Reduces Cardiovascular Events In People With Type 2 Diabetes With Atherosclerotic Cardiovascular And/or Chronic Kidney Disease: Primary Results From The SOUL Randomized Trial

Presentation Time: Saturday, March 29, 2025, from 1:30-1:40 PM CT

Presenter: Darren McGuire, MD

Description: SOUL is a multi-center, international, randomized, double-blind, parallel-group, placebo-controlled, phase 3 cardiovascular outcomes trial assessing the effect of once-daily oral semaglutide (Rybelsus) versus placebo on cardiovascular outcomes in 9650 people with T2D and established cardiovascular disease (CVD) and/or chronic kidney disease (CKD).

Headline results reported by Novo Nordisk found SOUL achieved its primary objective by demonstrating a statistically significant and superior reduction in major adverse cardiovascular events (MACE) of 14% with oral semaglutide treatment compared with placebo.

Dapagliflozin In Patients Undergoing Transcatheter Aortic Valve Implantation

Presentation Time: Saturday, March 29, 2025, from 2:15-2:25 PM CT

Presenter: Sergio Raposeiras Roubin, MD, PhD

Description: Patients undergoing transcatheter aortic valve implantation (TAVI) for aortic stenosis relief are at an elevated risk of developing heart failure (HF) within the first months of intervention. In the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) trial, investigators sought to assess the clinical benefit and safety of dapagliflozin 10 mg/day on mortality and worsening HF in 1020 patients with severe AS undergoing TAVI

For the independent pragmatic, controlled, prospective, randomized, open-label blinded endpoint, multicenter trial in Spain, patients needed a prior history of HF admission plus diabetes mellitus, left ventricular ejection fraction (LVEF) ≤40%, or estimated glomerular filtration rate (eGFR) between 25 and 75 ml/min/1.73 m2.

Relevant disclosures for Bhatt include Amarin, AstraZeneca, Sanofi, Pfizer, Roche, Amgen, and Eli Lilly and Company, among others.

References

1. Bonaca MP, Catarig AM, Hansen Y, et al. Design and baseline characteristics of the STRIDE trial: evaluating semaglutide in people with symptomatic peripheral artery disease and type 2 diabetes. Eur Heart J Cardiovasc Pharmacother. 2025;10(8):728-737. doi:10.1093/ehjcvp/pvae071

2. Oral semaglutide demonstrates a 14% reduction in risk of major adverse cardiovascular events in adults with type 2 diabetes in the SOUL trial. Novo Nordisk. October 21, 2025. Accessed March 21, 2025. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=171480.

3. Amat-Santos IJ, Sánchez-Luna JP, Abu-Assi E, et al. Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial. Eur J Heart Fail. 2022;24(3):581-588. doi:10.1002/ejhf.2370