[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627219":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":25,"responsibleParty":43,"collaborators":25,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":25,"enrollmentInfo":54,"targetDuration":25,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":68,"whyStopped":25,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":25},{"fullName":5,"class":6},"Martini Hospital Groningen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"verapamil","EXPERIMENTAL","rate control with verapamil 240 mg od",[13],"Drug: Verapamil 240 mg slow-release tablet",{"label":15,"type":16,"description":17,"interventionNames":18},"metoprolol","ACTIVE_COMPARATOR","rate control with metoprolol 100 mg od",[19],"Drug: metoprolol 100 mg slow-release tablet",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Verapamil 240 mg slow-release tablet",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"metoprolol 100 mg slow-release tablet","Rate control with metoprolol 100 mg od",[15],[31],{"name":32,"affiliation":5,"role":33},"Robert G Tieleman, MD, PhD","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+31505245245","r.tieleman@gmail.com",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Scientific Department Martini Hospital","+31505246311","wetenschap@mzh.nl",{"type":44,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100627219","phase-4-smart-verapaf-self-management-and-random-therapy-with-verapamil-or-metoprolol-in-paroxysmal-atrial-fibrillation-100627219",false,"NCT07445789","SMART-VERAPAF: Self-MAnagement and Random Therapy With VERApamil or Metoprolol in Paroxysmal Atrial Fibrillation","SMART-VERAPAF","7.2 Inclusion criteria\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Age ≥ 18 years old\n* ECG documented diagnosis of paroxysmal AF\n* 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\n* Able and willing to sign informed consent.\n\nFor SMART sub study only:\n\n\\- Own a smartphone\n\n7.3 Exclusion criteria\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* A history of electrical cardioversion for persistent AF\n* History of AF episode \\> 7 days\n* Previous or current chronic amiodaron use.\n* A history of pulmonary vein ablation\n* Taking part in another randomized trial\n* Reduced life-expectancy of \\\u003C 1 year\n* Presence of contra-indication for verapamil or metoprolol\n* Pregnant or breastfeeding women. Or women who are planning to become pregnant during the study period.\n* For substudy patients: already participating in an eHealth program\n\nContraindications for verapamil or metoprolol:\n\n* Known hypersensitivity, intolerance or allergy to verapamil, metoprolol, or any excipi-ents.\n* Current use of verapamil, diltiazem, beta-blockers or digoxin, or \\\u003C 5 half-lives ago at the time of randomization.\n* Concomitant use of medications with absolute contraindications for verapamil or metoprolol (e.g., strong CYP3A4 inhibitors).\\*\n* Resting heart rate \\\u003C 50 beats per minute at baseline.\n* Symptomatic hypotension (or systolic blood pressure \\\u003C 100 mmHg).\n* Second- or third-degree atrioventricular block.\n* Sick sinus syndrome or sinus node disease.\n* Wolff-Parkinson-White syndrome.\n* Severe heart failure (NYHA class III-IV or left ventricular ejection fraction \\\u003C 45%).\n* Clinically significant constipation requiring medical intervention.\n* Severe bronchial asthma or COPD with bronchial hyperreactivity.\n* Untreated pheochromocytoma (unless patient is concomitantly treated with an α-blocker).\n* Type 1 diabetes mellitus with frequent symptomatic hypoglycaemia where β-blocker use would pose unacceptable risk due to masking of symptoms.\n* Severe symptomatic peripheral arterial disease or disabling Raynaud's phenomenon.\n* Pacemaker therapy in place. An implanted loop recorder is not a contraindication.\n* Severe hepatic impairment (Child-Pugh class C).\n* Severe renal impairment (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m²). \\*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.","ALL","18 Years",{"count":55,"type":56},436,"ESTIMATED","INTERVENTIONAL",[59],"PHASE4","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.\n\nThe 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.",[62],"Atrial Fibrillation (AF)",[64,9,15,65,66,67],"atrial fibrillation","rate control","rhythm control","paroxysmal","NOT_YET_RECRUITING","2026-03-23",{"date":71,"type":72},"2026-03-27","ACTUAL",{"date":74,"type":56},"2026-06",{"date":76,"type":56},"2029-06",{"name":5,"class":6}]