drugset / Trial / NCT07445789

SMART-VERAPAF: Self-MAnagement and Random Therapy With VERApamil or Metoprolol in Paroxysmal Atrial Fibrillation

NCT07445789

Phase 4 Not yet recruiting 436 enrolled Martini Hospital Groningen
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The SMART-VERAPAF study investigates the effects of different heart rate-lowering medications in patients with paroxysmal atrial fibrillation (AF). This heart rhythm disorder is associated with a large number of emergency room visits and hospitalizations for cardioversions and ablations. In this study, patients with symptomatic paroxysmal AF are randomized to treatment with heart rate reduction using verapamil or metoprolol, both licensed for this indication. In addition, in a subset of patients, the effect of centrally guided self-care using smartwatch data will be evaluated. The hypothesis is that both verapamil and guided self-care will lead to better heart rate control and fewer cardioversions and pulmonary vein ablations in patients with paroxysmal AF. This will also result in fewer hospital admissions, outpatient visits, and costs, as well as improved quality of life.

Timeline

Start
2026-06
Primary completion
2029-06
Completion
2029-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metoprolol Other / unclassified 100 mg Oral
Subject Verapamil Other / unclassified 240 mg Oral

Indications