NCT07445789

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 436 (estimated)
• Sponsor: Martini Hospital Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Rationale In patients with paroxysmal atrial fibrillation (AF), heart rate-suppressing therapy is used to reduce symptoms and prevent heart failure. However, recent studies show that more than 30% of paroxysmal AF patients experience inappropriate high heart rates for over 50% of the time while in AF. Most patients are treated with beta-blockers for adequate rate control, while less than 5% are treated with verapamil. Hypothesis and objectives The investigators hypothesize that treatment with verapamil is superior for heart rate suppression in patients with paroxysmal AF, because dose titration is not hampered by sinus bradycardia outside AF episodes. This advantage is expected to lead to less clinical progression of AF and therefore fewer AF-related hospital admissions, fewer cardioversions, and fewer referrals for ablation. Additionally, the investigators hypothesize that guided self-management using smartwatch data improves the quality of heart rate suppression, resulting in fewer symptoms, fewer unplanned hospital admissions, fewer cardioversions, and fewer referrals for ablation. Main trial endpoints The primary outcome measure is the time to hospitalization for AF, cardioversion, or referral for pulmonary vein ablation during at least 1 year follow-up after randomization. Secondary trial endpoints Secondary outcome measures include hospitalizations for heart failure, the number of AF-related hospital days, outpatient visits for AF, echocardiographic parameters, heart rate and blood pressure, quality of life, symptoms, activity level, and costs. Trial design This is a multicenter, prospective, double-blind randomized study with blinded endpoint assessment. A sub-study will investigate feasibility and efficacy of guided self-management using smartwatches. Follow-up duration is at least 1 year after randomization. Trial population Symptomatic patients with paroxysmal AF, ≥18 years of age, who have an indication for rate-control therapy. Patients with contraindications for verapamil or metoprolol, a history of persistent AF, or prior pulmonary vein ablation will be excluded. Interventions A total of 436 participants will be randomized to receive oral verapamil 240 mg slow-release or metoprolol 100 mg retard. A subset of participants will monitor heart rate using a smartwatch and adjust the study medication dose using heart rate data and a flow chart supported by a central service center. Sample size and data analysis A total of 436 patients with paroxysmal AF will be randomized. Endpoints will be analyzed according to the intention-to-treat (ITT) principle using standard statistical techniques.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2026-03-03
• Last updated: 2026-03-27