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Take a look at 7 major clinical trials to keep an eye on for the upcoming ESC Congress from August 29-September 1, 2025.
The European Society of Cardiology (ESC) will kick off its 2025 annual meeting in Madrid, Spain, on August 29, 2025. Championing the diverse knowledge, innovation, and expertise of the global cardiology community, the ESC Congress stands as one of the premier meetings across any discipline and the largest annual meeting dedicated to cardiology care in the world, with ESC Congress 2024 drawing 32,000 health professionals from 171 countries.
The nomenclature used at ESC Congress differs from other major meetings, opting to use Hot Line Sessions for their most impactful data, with 10 sessions in total during ESC Congress 2025, which will be held in Main Auditorium. These sessions are reserved for first presentation of the primary endpoint of novel clinical trials, recently completed and unpublished.
The meeting’s late-breaking sessions are topic-related sessions featuring the trials, trial updates and registries, cohorts, observational, and epidemiological studies. There are 28 late-breaking sessions encompassing more than 100 presentations in total.
With such a bevy of forthcoming science, our editorial team has compiled a list of 7 trials to watch at the upcoming ESC Congress 2025.
Vericiguat is a soluble guanylate cyclase stimulator, approved in several countries to treat worsening heart failure with reduced ejection fraction (HFrEF). The VICTORIA trial showed reduced risk of hospitalization for heart failure and reduced cardiovascular death in patients with HFrEF and a left ventricular ejection fraction with worsening heart failure. The VICTOR trial, a double-blind, placebo-controlled, parallel group, randomized trial, was designed to compare vericiguat against placebo in patients with HFrEF without worsening heart failure.
The DAPA ACT HF-TIMI 68 trial, an investigator-initiated, randomized, double-blind, placebo-controlled trial, was constructed to investigate the effect of in-hospital dapagliflozin on the clinical outcomes of worsening heart failure or cardiovascular death in patients with heart failure who have been stabilized during hospitalization. Participants were assigned to either dapagliflozin 20 mg or matching placebo, administered daily for 2 months.
A phase 3 trial conducted by Bristol Myers Squibb, ODYSSEY-HCM evaluated mavacamten for adult patients with symptomatic New York Heart Association (NYHA) class II or III non-obstructive hypertrophic cardiomyopathy. The trial failed to reach its dual primary endpoitns of peak oxygen consumption and changes from baseline compared to placebo in the Kansas City Cardiomyopathy Questionnaire. Investigators will be presenting detailed results at ESC 2025.
Baxdrostat, a potential first-in-class, highly selective aldosterone synthase inhibitors (ASI) targeting the hormone causing increased cardiovascular and renal risk, has proven its efficacy and safety in treating difficult-to-control hypertension. BaxHTN was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study evaluating the safety, tolerability, and efficacy of baxdrostat; it achieved all endpoints in July of 2025. Specifically, 2 distinct doses of baxdrostat – 2mg and 1mg – displayed significant reductions in mean seated systolic blood pressure compared to placebo at 12 weeks. The detailed results of BaxHTN will be presented in a late-breaking session at ESC 2025.
ESSENCE CS9 TIMI 73b, a phase 3, multicenter, randomized, double-blind, placebo-controlled trial including roughly 1300 patients, was constructed to test the efficacy of olizarsen in changing triglyceride levels from baseline. Olizarsen is an antisense oligonucleotide inhibitor of apoC-III production and is administered subcutaneously. The end results of the ESSENCE-TIMI trial will be presented at ESC 2025 during Hot Line 4.
Inclisiran, a synthetic, double-stranded RNA oligonucleotide designed to silence PCSK9 genes in hepatocytes, is designed to significantly reduce LDL-C in patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalent. VICTORION-Difference included patients with hypercholesterolemia at high or very high cardiovascular risk, despite having been treated with an individualized maximally tolerated statin dose. The phase 4, randomized, double-blind, placebo-controlled trial investigated inclisiran’s effects on quality of life compared to placebo in patients with atherosclerotic cardiovascular disease.
This multicenter, superiority, open-label randomized clinical trial aimed to compare pulse field ablation (PFA) against radiofrequency (RF) ablation, examining the efficacy and safety of each for patients with drug-resistant paroxysmal atrial fibrillation. BEAT PAROX-AF had a primary endpoint of 1-year recurrence of atrial arrhythmia, with a major secondary safety endpoint of occurrence of acute procedure-related serious adverse events, or pulmonary vein stenosis, or atrio-esophageal fistula up to 12 months. The study was concluded in January of 2024, and the results will be presented at ESC 2025.
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