Heart Failure in 2025: Year in Review

Heart failure (HF) has seen a series of dramatic shifts during the past year. Between the groundbreaking joint statement from the Heart Failure Society of America (HFSA) and the American Society for Preventive Cardiology (ASPC) calling for a shift towards preventive care in HF to the US Food and Drug Administration (FDA)'s approval of bumetanide nasal spray and finerenone, a substantial amount of progress has been made in improving the efficacy and availability of HF care.

Given the sheer volume of critical news released during 2025, the editorial team at HCPLive has collected 12 of the most impactful headlines from the past 12 months. Catch up on any major news you might have missed below.

FDA News

FDA Updates Mavacamten Label in Obstructive Hypertrophic Cardiomyopathy

On April 17, 2025, the FDA updated mavacamten’s prescribing information for treating adults with New York Heart Association (NYHA) Class II-III obstructive hypertrophic cardiomyopathy (oHCM), aiming to simplify echo monitoring requirements for eligible patients in the maintenance phase. This decision reduced the frequency of required echo monitoring from once every 12 weeks to once every 6 months for patients with left ventricular ejection fraction (LVEF) ≥55% and a Valsalva LVOT gradient ≤30 mmHg who reached the maintenance phase at 12 weeks or later. The decision also expanded patient eligibility by reducing contraindications, such as those with moderate CYP2C19 inhibitors and strong CYP3A4 inhibitors.

FDA Approves Finerenone (Kerendia) for Heart Failure with Ejection Fraction of 40% or More

On July 14, 2025, the FDA approved finerenone for reducing the risk of cardiovascular death, hospitalization for HF, and urgent HF visits in adults with HF with mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF). This approval was based on results from the FINEARTS-HF trial, which saw finerenone substantially reduce the incidence of the above endpoints by 16% compared to placebo.

FDA Approves Aficamten (Myqorzo) for Symptomatic Obstructive Hypertrophic Cardiomyopathy

On December 19, 2025, the FDA announced its approval of aficamten tablets in 5 mg, 10 mg, 15 mg, and 20 mg doses to treat oHCM, aiming to improve functional capacity and symptoms. The allosteric and reversible inhibitor of cardiac myosin motor activity proved its safety and efficacy in the phase 3 SEQUOIA-HCM trial, which compared its impact on exercise capacity versus placebo.

FDA Approves Bumetanide Nasal Spray for Edema with Congestive Heart Failure

On September 15, 2025, Corstasis Therapeutics announced the FDA’s approval of bumetanide nasal spray to treat edema associated with congestive heart failure (CHF), liver disease, and chronic kidney disease (CKD). This intranasal loop diuretic is designed to circumvent the absorption presented by overreliance on intravenous loop diuretics. During the RSQ-777-02 trial, the nasal spray proved its equivalence to oral bumetanide, as well as displaying a higher time to maximum concentration compared to oral administration.

Trial Updates and New Guidelines

HFSA and ASPC Release Statement on Shifting to Prevention in Heart Failure

On August 13, 2025, the HFSA and ASPC released a joint statement addressing the need for the prioritization of prevention and risk identification in HF care. The document calls for clinicians to take a more active role in identifying risk factors in patients, noting major drivers of the pathophysiologic cascade, such as inflammation. Additionally, the publication names a series of preventive factors for lifelong HF control, such as improved sleep, regular exercise, weight management, and control of blood pressure, cholesterol, and glycemia. Ultimately, the document breaks down 4 primary components of HF prevention: early risk identification, holistic care, proven therapies, and system-wide change.

Finerenone Limits Outpatient Oral Diuretic Intensification in Heart Failure

A secondary analysis of the FINEARTS-HF trial proved in February of 2025 that finerenone has the capacity to prevent outpatient worsening HF events requiring oral diuretic intensification in patients with mildly reduced or preserved ejection fraction. In addition to further indicating the benefit of finerenone in decreasing worsening HF events, the trial was also cited as a major argument in favor of adopting outpatient oral diuretic intensification as an indicator of worsening HF.

DAPA-EAT: Dapaglifozin Reduces Epicardial Adipose Tissue in Patients with Asymptomatic HF

DAPA-EAT was presented at the American Heart Association’s Scientific Sessions in New Orleans, Louisiana, highlighting dapagliflozin’s substantial efficacy in reducing epicardial adipose tissue (EAT), left ventricular myocardial fibrosis and volume, and improved diastolic filling dynamics in patients with asymptomatic HF. During the trial, dapagliflozin reduced EAT by 15.6 mL compared to the control cohort’s 9.6 mL reduction. However, most echocardiographic parameters showed no significant differences, with no changes observed in the biomarkers of the E/A ratio.

SURPASS-CVOT: Tirzepatide Bests Dulaglutide for Cardiovascular Protection

On July 31, 2025, Eli Lilly and Company announced positive topline results from the head-to-head phase 3 SURPASS-CVOT trial, which compared tirzepatide and dulaglutide in adults with type 2 diabetes and atherosclerotic cardiovascular disease. During the trial, tirzepatide demonstrated a non-inferior rate of major adverse cardiovascular events, including cardiovascular death, heart attack, and stroke, compared to dulaglutide. Additionally, although the trial was not controlled for multiplicity-adjusted type-1 error, tirzepatide also resulted in improvements on measures of A1C, weight, renal function, and all-cause mortality.

Feature Content/Podcasts

HFSA/ASPC Heart Failure Prevention: From Prognosis to Prevention in Heart Failure

Following the joint statement from the ASPC and HFSA, HCPLive hosted a 7-part special report to break down the new framework and its establishment of HF as a preventable condition. In this first episode, moderator James Januzzi, MD, is joined by Martha Gulati, MD, MS, and Anu Lala, MD, to highlight the need to bridge the gap between HF care and preventive cardiology. Despite remaining largely preventable, HF is a rapidly growing epidemic with high costs to both clinicians and patients. Preventive cardiology and HF care have traditionally been separate, but Gulati and Lala emphasize the importance of unifying the 2 fields via the new statement.

Don't Miss a Beat: Vericiguat in Heart Failure and the VICTOR Trial, With Javed Butler, MD

Although the VICTOR trial, which investigated vericiguat in patients with ambulatory HFrEF who had received contemporary background therapy, failed to achieve its primary endpoint, it did display fewer cardiovascular and all-cause deaths. Given this, investigators have suggested vericiguat may prove beneficial in ambulatory HFrEF when combined with optimal background therapy. To further discuss this, cohosts Stephen Greene, MD, and Muthiah Vaduganathan, MD, MPH, spoke with Javed Butler, MD, to discuss vericiguat’s potential as a mortality-reducing therapy in HFrEF and its possible place in an emerging “quintuple therapy” standard.

Don't Miss a Beat: Debating Oral Diuretic Intensification as an Endpoint in Heart Failure Trials

This episode centered around the ongoing debate for establishing oral diuretic intensification, particularly in light of its frequency and prognostic value, as an endpoint for future HF trials. Additionally, in comparison to historical endpoints, including all-cause mortality and HF hospitalization, oral diuretic intensification may potentially increase event capture in future clinical trials. However, definitions of oral diuretic intensification vary across studies, ranging from dose doubling to drug class switching and short-term use of additional diuretics. Still, the prognostic importance of this measurement makes it worth considering, even with the required overhauls to both definition and trial frameworks prior to its implementation.

Don't Miss a Beat: POLY-HF & the Potential of Polypills in HF, With Ambarish Pandey, MD

In this episode, recorded onsite at the 2025 American Heart Association Scientific Sessions in New Orleans, saw Greene and Vaduganathan meet with Ambarish Pandey, MD, from UT Southwestern, to discuss the POLY-HF trial – specifically, the novel concept of a polypill approach to HFrEF. The trial tested a singular pill including 3 GDMT classes – metoprolol succinate, spironolactone, and empagliflozin – in the enhancement of treating adherence and cardiac function compared to usual care. Patients receiving the polypill demonstrated a 3.4% greater improvement in LVEF, as well as a 50% reduction in recurrent HF hospitalizations.