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

A regiszterben nem jelölt feltételek

• 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.