Don't Miss a Beat: REBALANCE-HF, with Marat Fudim, MD, MHS

The largest annual heart failure-specific meeting in the US, the Heart Failure Society of America (HFSA) Annual Scientific Meeting serves as a showcase for the latest innovations, advancements, and revelations, not only for advanced heart failure and transplant specialists, but the continuum of the care team.

There may be no better example of this than the meeting’s sessions dedicated to late-breaking clinical trials. Among the trials headlining this year’s late-breaking session was the REBALANCE-HF trial, which was presented by Marat Fudim, MD, MHS, advanced heart failure specialist at Duke University Medical Center.

Billed by Axon Therapies as the largest randomized controlled, blinded, feasibility device trial in patients with heart failure with preserved ejection fraction (HFpEF) to date, REBALANCE-HF examined the safety and initial effectiveness of catheter-based unilateral ablation of the right greater splanchnic nerve in patients with HFpEF.

During his presentation, Fudim highlighted the safety and tolerability of the procedure, which had a 98% success rate and had a mean time to completion of less than an hour. In their release, Axon Therapies highlighted the following findings:

• 13-point improvement in quality-of-life at 6 months in treatment vs. sham (P= .02) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) score
• 36-meter improvement in ability to walk at 6 months in treatment vs. sham (P=.08) as measured by the 6-minute walk test
• 39% relative improvement in cardiac function at 6 months in treatment vs. sham (P=.10)
• Reduced filling pressures at 1 month as measured by peak pulmonary capillary wedge pressure of -4.5 mmHg (vs. peak PCWP of -1.6 mmHg for sham, P=.10).

With an interest in learning more about the trial, results, and what it could mean for patients with HFpEF, the hosts of Don’t Miss a Beat, Muthiah Vaduganathan, MD, MPH, and Steve Greene, MD, reached out to Fudim to take part in a special edition episode recorded at HFSA 2023 in Cleveland, OH.

Vaduganathan reports having received funding for consulting or research grants from Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, Lexicon, and others.

Greene reports having received funds for consulting or research grants from Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, and others.

Fudim reports having received funds for consulting or research grants from Axon Therapies, Daxor, Bayer Corporation, Abbott Laboratories, and others.

References:

1. Fudim M, Borlaug B, Pierce MJ, et al. Endovascular Ablation of The Right Greater Splanchnic Nerve In Heart Failure With Preserved Ejection Fraction: Responder Analysis Of The Rebalance-hf Randomized Trial. Paper presented at: Heart Failure Society of America 2023 Annual Scientific Meeting; October 6 - 9; Cleveland, OH. Accessed October 8, 2023.
2. Axon Therapies. Late-breaking data confirms safety of Axon Therapies’ innovative heart failure procedure and identifies patients most likely to benefit from SAVM therapy. PR Newswire: press release distribution, targeting, monitoring and marketing. October 8, 2023. Accessed October 8, 2023. https://www.prnewswire.com/news-releases/late-breaking-data-confirms-safety-of-axon-therapies-innovative-heart-failure-procedure-and-identifies-patients-most-likely-to-benefit-from-savm-therapy-301950021.html?tc=eml_cleartime.