SMART-VERAPAF: Self-MAnagement and Random Therapy With VERApamil or Metoprolol in Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 436
- 主要终点
- The time to hospitalization for AF, cardioversion, or referral for pulmonary vein ablation
研究概览
简要总结
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.
详细描述
Rationale
In patients with paroxysmal atrial fibrillation (AF), heart rate-suppressing therapy is used to reduce symptoms and prevent heart failure. However, recent studies show that more than 30% of paroxysmal AF patients experience inappropriate high heart rates for over 50% of the time while in AF. Most patients are treated with beta-blockers for adequate rate control, while less than 5% are treated with verapamil.
Hypothesis and objectives
The investigators hypothesize that treatment with verapamil is superior for heart rate suppression in patients with paroxysmal AF, because dose titration is not hampered by sinus bradycardia outside AF episodes. This advantage is expected to lead to less clinical progression of AF and therefore fewer AF-related hospital admissions, fewer cardioversions, and fewer referrals for ablation. Additionally, the investigators hypothesize that guided self-management using smartwatch data improves the quality of heart rate suppression, resulting in fewer symptoms, fewer unplanned hospital admissions, fewer cardioversions, and fewer referrals for ablation.
Main trial endpoints
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
verapamil
rate control with verapamil 240 mg od
干预措施: Verapamil 240 mg slow-release tablet (Drug)
metoprolol
rate control with metoprolol 100 mg od
干预措施: metoprolol 100 mg slow-release tablet (Drug)
结局指标
主要结局
The time to hospitalization for AF, cardioversion, or referral for pulmonary vein ablation
时间窗: follow-up duration is at least 1 year after randomisation and can range from 1 to 3 years
次要结局
未报告次要终点