FRIDAY, May 29, 2026 (HealthDay News) -- For patients with heart failure, insertable cardiac monitor (ICM)-based high-risk detection combined with centrally managed, nurse-facilitated, individually protocolized diuretic interventions are safe but did not lead to a change in heart failure outcomes, according to a study published online May 27 in the Journal of the American College of Cardiology.
Javed Butler, M.D., M.P.H., from the Baylor Scott and White Research Institute in Dallas, and colleagues examined whether ICM-based high-risk detection combined with centrally managed, nurse-facilitated, individually protocolized diuretic interventions are safe and improve heart failure outcomes. Participants with heart failure were randomly assigned to an intervention arm (high-risk heart failure alert-triggering protocolized diuretic regimen) or an observation arm (standard care; 357 and 354 participants, respectively).
The researchers found that 59.9 percent of participants had at least one high-risk episode in the randomized period, including 54.4 percent of those with left ventricular ejection fraction <50 percent and 62.5 percent with heart failure with preserved ejection fraction. The primary composite efficacy end point did not differ significantly between the groups (win ratio: 0.79; 95 percent confidence interval, 0.62 to 1.01; P = 0.06). The serious adverse events rate was 0.32 percent during a mean follow-up of 17.3 ± 8.9 months (prespecified safety threshold ≤5 percent). The intervention group had numerically higher cumulative cardiovascular death and heart failure events (hazard ratio, 1.43; 95 percent confidence interval, 0.95 to 2.15; P = 0.091). At 13 months after randomization, 67.2 percent of participants had a device-detected arrhythmia.
"These insights from the ALLEVIATE-HF clinical trial have brought to light a striking burden of clinically meaningful arrhythmias in a broad group of symptomatic heart failure patients, which until this point, had been underappreciated," coauthor Rami Kahwash, M.D., from The Ohio State University Wexner Medical Center in Columbus, said in a statement.
Several authors disclosed ties to biopharmaceutical and medical technology companies, including Medtronic, which funded the study.
