SMART-VERAPAF: Self-MAnagement and Random Therapy With VERApamil or Metoprolol in Paroxysmal Atrial Fibrillation
NCT07445789 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 436
Last updated 2026-03-27
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.
Conditions
- Atrial Fibrillation (AF)
Interventions
- DRUG
-
Verapamil 240 mg slow-release tablet
rate control with verapamil 240 mg od
- DRUG
-
metoprolol 100 mg slow-release tablet
Rate control with metoprolol 100 mg od
Sponsors & Collaborators
-
Martini Hospital Groningen
lead OTHER
Principal Investigators
-
Robert G Tieleman, MD, PhD · Martini Hospital Groningen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2029-06-30
- Completion
- 2029-06-30
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