Can a smartwatch help control a common heart rhythm problem?
NCT ID NCT07445789
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two common heart rate-lowering drugs, verapamil and metoprolol, in 436 adults with paroxysmal atrial fibrillation (AF). It also tests whether using a smartwatch for self-care can reduce hospital visits and improve symptoms. The goal is to find better ways to manage AF and avoid emergency care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- verapamil or metoprolol
- What this could lead to
- If successful, this could show that verapamil or smartwatch-guided self-care reduces hospital visits and improves quality of life for people with paroxysmal atrial fibrillation.
- What could go wrong
- This is a phase 4 trial, so both drugs are already approved, but results may not apply to all AF patients. The smartwatch component depends on patient engagement and may not show clear benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 436 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \< 50 beats per minute at baseline. * Symptomatic hypotension (or systolic blood pressure \< 100 mmHg). * Second- or third-degree atrioventricular block. * Sick sinus syndrome or sinus node disease. * Wolff-Parkinson-White syndrome. * Severe heart failure (NYHA class III-IV or left ventricular ejection fraction \< 45%). * Clinically significant constipation requiring medical intervention. * Severe bronchial asthma or COPD with bronchial hyperreactivity. * Untreated pheochromocytoma (unless patient is concomitantly treated with an α-blocker). * Type 1 diabetes mellitus with frequent symptomatic hypoglycaemia where β-blocker use would pose unacceptable risk due to masking of symptoms. * Severe symptomatic peripheral arterial disease or disabling Raynaud's phenomenon. * Pacemaker therapy in place. An implanted loop recorder is not a contraindication. * Severe hepatic impairment (Child-Pugh class C). * Severe renal impairment (eGFR \< 30 ml/min/1.73m²). \*Patients using statins can be switched to an equivalent dose of rosuvastatin prior to ran-domization. Patients using oral anticoagulation need to be switched to apixaban or rivaroxa-ban.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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