HFSA Highlights Late-Breaking Heart Failure Clinical Research

Washington, D.C., September 20, 2026

HFSA 2026 Program Highlights Novel Heart Failure Therapies

One of the major areas of the late-breaking program is pharmacotherapy, with new clinical data scheduled from trials evaluating investigational and established treatments for different forms of heart failure. The Sunday plenary session includes the Cycle-1 REF Phase 2 randomized, double-blind, placebo-controlled trial evaluating tovinontrine in patients with chronic heart failure with reduced ejection fraction (HFrEF). A related Cycle-2 PEF Phase 2 study will examine the safety and effectiveness of tovinontrine in patients with chronic heart failure with preserved ejection fraction (HFpEF). The program also includes new findings from the CARDIO-TTRansform trial evaluating eplontersen in patients with transthyretin amyloid cardiomyopathy. Additional research will examine aficamten in nonobstructive hypertrophic cardiomyopathy through the ACACIA-HCM program. These studies reflect ongoing efforts to develop therapies that address different biological mechanisms and clinical phenotypes associated with heart failure and cardiomyopathy.

Because these studies are scheduled for presentation during the meeting, their inclusion in the program does not itself establish their eventual clinical findings. HFSA states that late-breaking research is subject to strict embargo rules until the relevant presentation, and pre-embargo announcements may describe the study design and research question but may not disclose results.

Cardiac Imaging and Diagnostics Take Center Stage

The 2026 meeting will also showcase advances in cardiac imaging and diagnostics, including a prospective multicenter Phase 3 study of 124I-evuzamitide amyloid-targeted PET/CT. The research is evaluating the potential of this imaging approach to detect early cardiac amyloidosis without requiring an invasive biopsy. Cardiac amyloidosis can contribute to heart failure and cardiomyopathy, making earlier and less-invasive identification an important area of cardiovascular research. Other research presented during the meeting will examine biomarkers and diagnostic approaches across the heart-failure spectrum. The POSEIDON study, for example, will report on cardiovascular inflammation and associated patient characteristics and biomarker profiles in the United States. Additional rapid-fire presentations will explore transthyretin biomarkers, pulmonary artery pressure monitoring, remote sensing and other approaches to identifying changes in patients with heart failure. These studies demonstrate the expanding role of precision diagnostics and remote monitoring in cardiovascular medicine. Alongside conventional clinical measurements, researchers are increasingly evaluating imaging, biomarkers and sensor-derived information to better characterize disease and potentially identify patients at risk of worsening heart failure.

Device Therapy and Real-World Outcomes Expand Research

The HFSA program also includes substantial research on device-based heart failure therapies. The Sunday plenary will feature one-year real-world clinical outcomes following cardiac contractility modulation therapy, based on a U.S. post-approval study. Another presentation will report real-world outcomes following baroreflex activation therapy through the REBALANCE registry. The Monday program includes additional device-focused research, including studies of cardiac microcurrent therapy. The C-MIC II and C-MIC III programs will examine effects on exercise capacity and six-month outcomes in patients receiving subcutaneous cardiac microcurrent therapy. Rapid-fire sessions will also address pulmonary artery pressure monitoring, home monitoring of peripheral edema and other technologies designed to improve heart-failure management.

The breadth of the HFSA 2026 late-breaking program illustrates how heart failure research is expanding across medicines, diagnostics, monitoring technologies and medical devices. With randomized trials, prospective studies and real-world evidence represented across the agenda, the meeting will provide a platform for researchers to present new evidence and place emerging approaches in the context of contemporary heart-failure care. For cGxP.wire readers, the HFSA 2026 Annual Scientific Meeting represents an important clinical-research event because its late-breaking program spans multiple areas of cardiovascular innovation. The scheduled studies include Phase 2 and Phase 3 drug trials, biomarker and imaging research, and real-world evaluations of device therapies, making the meeting relevant to pharmaceutical, biotechnology, MedTech and clinical research audiences.

Source: HFSA press release