Arrhythmia Prevention in High Risk Cardiovascular Patients Using Targeted Potassium Levels
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
- 试验地点
- 6
- 主要终点
- Time to first occurrence of ECG documented ventricular tachycardia, appropriate ICD therapy, hospitalization > 24 hours due to arrhythmias and/or heart failure leading to a change in treatment and all cause mortality
研究概览
简要总结
This study evaluates whether a rigorously controlled high-normal level of serum-potassium (4.5-5.0 mEq/L) using dietary recommendations, potassium supplements and mineralocorticoid receptor antagonists will results in a lower incidence of cardiac arrhythmias in patients with an ICD. Patients will be randomized to this treatment or a control arm, where patients will receive usual guideline recommended follow-up.
详细描述
There is solid evidence that potassium-sparing drugs increase survival and ameliorates symptoms in heart failure patients and post-hoc studies have suggested that high-normal levels of blood potassium levels (p-K) markedly decreases the risk of malignant arrhythmias in cardiovascular patients.
This trial will randomize patients implanted with implantable cardioverter defibrillators (ICDs), who remain at high risk of life-threatening cardiac arrhythmias, to a standard therapy or standard therapy plus a regimen to keep high-normal p-K levels. The study will enroll 1,000 patients from the outpatient pacemaker clinics at Rigshospitalet and Gentofte hospital. Using a planned regime to increase p-K using inexpensive drugs and potassium supplements, the patients enrolled and followed with regular controls as well as continuous monitoring using existing home monitoring systems over a period of 4 years for the primary endpoint of appropriate ICD therapy and all cause mortality. Including analysis, the trial will be running for 5 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Implantable cardioverter defibrillator (ICD) or cardiac resynchronization pacemaker with ICD (CRT-D).
- •Age >18 years
排除标准
- •Estimated glomerular filtration rate (eGFR) <30 ml/h
- •Pregnancy
- •Lack of ability to understand and sign informed consent
结局指标
主要结局
Time to first occurrence of ECG documented ventricular tachycardia, appropriate ICD therapy, hospitalization > 24 hours due to arrhythmias and/or heart failure leading to a change in treatment and all cause mortality
时间窗: Total 291 events, expected 6 years
A combination of: * ECG documented ventricular tachycardia \> 125 bpm lasting \> 30 seconds * Any appropriate ICD therapy as documented by the ICD or ECG * Any unplanned hospitalizations \> 24 hours due to arrhythmias and/or heart failure leading to a change in treatment, e.g., administration of new drugs, or change in doses of already prescribed drugs or invasive or non-invasive treatment. * All-cause mortality The time period with regards to the Time-to-Event Outcome Measures starts with the randomization of the patient. ECG documented tachycardia from ECGs or ICD interrogations will be obtained from hospitalizations or outpatients clinic visits via electronic records after patient consent. Information of ventricular tachyarrhythmia therapy will be obtained from home monitoring systems or interrogation of the ICD devices during in-clinic visits. Mortality will be obtained from danish electronic hospital files or the danish death registry.
次要结局
- Time to first incidence of supraventricular arrhythmias as documented by ECG or the ICD(6 years)
- Proportion of patients experiencing <92 % CRT-pacing for > 2 weeks (only CRT-D patients)(6 years)
- Time to first hospitalization for heart failure(6 years)
- Time to first hospitalization for cardiac arrhythmias(6 years)
- Time to hospitalization for electrolyte disturbances or kidney failure(6 years)
- First occurrence of appropriate ICD therapy for ventricular tachycardia or ventricular fibrillation irrespective of outcome.(6 years)
- Time to first occurence of inappropriate ICD therapy(6 years)
研究者
Christian Joens
Staff Cardiologist, Electrophysiology, Principal investigator, PhD
Rigshospitalet, Denmark