STOP-DHF (a non-invasive hemodynamic-guided strategy to prevent heart failure decompensation) trial: preliminary results of medical therapy interventions study

Background

Elevated left ventricular filling pressures (LVFP) typically precede heart failure (HF) decompensation by days to weeks. Non-invasive remote hemodynamic monitoring offers a promising approach for timely, targeted medication adjustments with the potential to improve clinical outcomes.

Purpose

This study aimed to characterize diuretic and guideline-directed medical therapy (GDMT) adjustments within a non-invasive, trigger-based hemodynamic surveillance strategy in the STOP-DHF (A Non-Invasive Hemodynamic-Guided Strategy to Prevent Heart Failure Decompensation) trial.

Methods

STOP-DHF was a prospective, multicenter, single-arm, pragmatic trial enrolling patients with chronic HF (NYHA class II–III), irrespective of left ventricular ejection fraction (LVEF). Non-invasive LVFP measurements were obtained using a CE-certified photoplethysmography-based system. Predefined hemodynamic alerts triggered structured clinical review and protocol-recommended medication adjustments. We analyzed changes in diuretics (loop and thiazide) and GDMT and assessed safety outcomes, including symptomatic hypotension, severe electrolyte disturbances, and renal function.

Results

In the overall STOP-DHF cohort, the primary composite endpoint of HF hospitalization or all-cause mortality at 6 months was significantly lower than the health-system–matched benchmark (4.2% vs 9.0%, p < 0.001; 95% CI 2.3–7.0%). We analyzed 330 patients (mean age 67 years; 36% women; 43% with LVEF ≤40%). Baseline use of diuretics and GDMT was high (Figure 1). Over a mean follow-up of 6 months, 269 medication changes were observed (0.136 changes/patient-month), including 169 (63%) up-titrations and 100 (37%) down-titrations (Figure 2). Up-titrations were more frequent than down-titrations overall, across both LVEF phenotypes (≤40% and >40%), and within both diuretics and GDMT (Figure 2; p < 0.05 for all).

The overall rate of medication changes was higher in patients with LVEF >40% compared with ≤40% (0.176 vs 0.083 changes/patient-month; RR 2.10, p < 0.001). In patients with LVEF >40%, both GDMT and diuretics were intensified with similar adjustment rates between classes (0.058 vs 0.049 changes/patient-month; RR 1.18, p = 0.36). In patients with LVEF ≤40%, GDMT intensifications exceeded the frequency of diuretic changes (0.038 vs 0.020 changes/patient-month; p = 0.04).

Estimated glomerular filtration rate did not change from baseline to 6 months (63.59 ± 23.36 vs 63.71 ± 23.69 mL/min/1.73 m²; paired t-test p = 0.92; n = 76 with paired data). Seven episodes of symptomatic hypotension were recorded, and no severe electrolyte disturbances occurred.

Conclusions

In the STOP-DHF trial, non-invasive LVFP-guided monitoring was associated with targeted adjustments in GDMT and diuretics. This approach was safe and associated with a significantly lower rate of the primary composite endpoint compared with a health-system–matched benchmark.

For image description, please refer to the figure legend and surrounding text. Medication changes by drug classes For image description, please refer to the figure legend and surrounding text.