SMART-VERAPAF: Self-MAnagement and Random Therapy With VERApamil or Metoprolol in Paroxysmal Atri… (NCT07445789) | Clinical Trial Compass
Not Yet RecruitingPhase 4
SMART-VERAPAF: Self-MAnagement and Random Therapy With VERApamil or Metoprolol in Paroxysmal Atrial Fibrillation
436 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
7.2 Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* 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.
For SMART sub study only:
\- Own a smartphone
7.3 Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* 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
* Taking part in another randomized trial
* Reduced life-expectancy of \< 1 year
* Presence of contra-indication for verapamil or metoprolol
* Pregnant or breastfeeding women. Or women who are planning to become pregnant during the study period.
* For substudy patients: already participating in an eHealth program
Contraindications for verapamil or metoprolol:
* Known hypersensitivity, intolerance or allergy to verapamil, metoprolol, or any excipi-ents.
* Current use of verapamil, diltiazem, beta-blockers or digoxin, or \< 5 half-lives ago at the time of randomization.
* Concomitant use of medications with absolute contraindications for verapamil or metoprolol (e.g., strong CYP3A4 inhibitors).\*
* Resting heart rate…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The time to hospitalization for AF, cardioversion, or referral for pulmonary vein ablation
Timeframe: follow-up duration is at least 1 year after randomisation and can range from 1 to 3 years