Cardiac Arrhythmia in Patients With End-Stage Renal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- Clinically significant arrhythmias
研究概览
简要总结
The study will examine the presence of cardiac arrhythmias in patients receiving hemodialysis and the role of diabetes, hypoglycemia and parameters related to uremia and the dialysis procedure.
The study is designed as a prospective cohort study with 18 months follow-up. 70 patients receiving chronic hemodialysis will be recruited and equipped with implantable loop recorders (ILR): 35 patients with diabetes and 35 patients without diabetes.
Data collection during the follow-up includes continuous monitoring of the heart rhythm by the ILR for the entire follow-up period, continuous glucose monitoring for 10 days every second month, and monthly collection of blood samples and dialytic parameters.
After the initial 18-month follow-up, heart rhythm monitoring will continue until the ILR battery runs out for those participants who wish to continue.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with diabetes:
- •Type 1 diabetes or Type 2 diabetes diagnosed according to the criteria of the World Health Organization
- •Treated with glucose-lowering drugs at inclusion
- •Receiving in-center maintenance hemodialysis for more than 3 months
- •Age ≥ 18 years
- •Patients without diabetes:
- •No known diagnosis of diabetes
- •No previous treatment with glucose-lowering drugs
- •HbA1c < 48 mmol/mol at screening
- •Receiving in-center maintenance hemodialysis for more than 3 months
- •Age ≥ 18 years
排除标准
- •For both groups:
- •Cardiac pacemaker or implantable cardioverter defibrillator (ICD)
- •Known permanent (chronic) atrial fibrillation
- •History of sustained (> 30 seconds) ventricular tachycardia (more than 200 bpm) or ventricular fibrillation (note that ventricular premature beats is not considered an exclusion criterion)
- •Known cardiac ion-channel disease (such as Long QT syndrome and Brugada syndrome)
- •Not suitable for implantation (left-sided dialysis catheter or other condition expected to interfere with implantation)
- •Previously complications in relation to wearing a CGM sensor, e.g. allergic reaction
- •Inability to give written informed consent
结局指标
主要结局
Clinically significant arrhythmias
时间窗: 18 months
Presence of one of the items in the combined endpoint of clinically significant arrhythmias defined as: * Significant bradyarrhythmia (pause \> 3 seconds or ≥ 4 beats at rate \< 30 beats/min) * Ventricular tachycardia (lasting ≥ 16 beats at rate ≥ 150 beats/min) * Ventricular fibrillation
次要结局
- All-cause mortality(18 months)
- Characterization of arrhythmias in terms of ventricular rate(18 months)
- Time above range (>13.9 mmol/L)(18 months)
- Arrhythmia leading to the implantation of a cardiac implantable electronic device(18 months)
- Supraventricular tachycardia other than atrial fibrillation(18 months)
- Time to clinically significant arrhythmias, atrial fibrillation, or supraventricular tachycardia, respectively(18 months)
- Time in range(18 months)
- Characterization of arrhythmias in terms of onset(18 months)
- Sudden cardiac death(18 months)
- Atrial fibrillation(18 months)
- Characterization of arrhythmias in terms of duration(18 months)
- Episodes of hypoglycemia(18 months)
- Time above range (>10.0 mmol/L)(18 months)
- Mean sensor glucose(18 months)
- Cardiovascular death(18 months)
- Time below range (<3.0 mmol/L)(18 months)
- Arrhythmia leading to a medical intervention(18 months)
- Adverse events(18 months)
- Time below range (<3.9 mmol/L)(18 months)
- Glycemic variability(18 months)
研究者
Bo Feldt-Rasmussen
Professor
Rigshospitalet, Denmark