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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMartini Hospital Groningen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old

ECG documented diagnosis of paroxysmal AF

Presence of symptomatic paroxysmal AF, defined as recurrent self-terminating AF (≥ 2 episodes in last 4 months) documented by typical symptoms, ECG or photoplethysmo-gram

Able and willing to sign informed consent.

Disqualifiers

A history of electrical cardioversion for persistent AF

History of AF episode > 7 days

Previous or current chronic amiodaron use.

A history of pulmonary vein ablation

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

436 Participants
are divided into 2 treatment groups
Group A: verapamilExperimental treatment 1 intervention
Group B: metoprololActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: