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

Sponsor
Martini Hospital Groningen
Study ID
NCT07445789
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Atrial Fibrillation (AF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Verapamil 240 mg slow-release tablet — DRUG
    rate control with verapamil 240 mg od
  • metoprolol 100 mg slow-release tablet — DRUG
    Rate control with metoprolol 100 mg od

Study Details

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.

Key Dates

First listed
Mar 3, 2026
Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
436 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: verapamil
    rate control with verapamil 240 mg od
  • Active Comparator: metoprolol
    rate control with metoprolol 100 mg od

Primary Outcome Measure

The time to hospitalization for AF, cardioversion, or referral for pulmonary vein ablation [ Time Frame: follow-up duration is at least 1 year after randomisation and can range from 1 to 3 years ]

Central Contacts

Related Studies