LINQ for impEdance meAsuremeNt While Off From HF Medication Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Derived-subcutaneous impedance
研究概览
简要总结
The purpose of this non-randomized, cross-over, unblinded, single-center feasibility study is to assess the sensitivity of the LINQ ICM to measure derived-subcutaneous impedance in patients with heart failure during periods when diuretics and/or HF-medication consumption is increased or suspended for 48 hours (up to 72 hours at physician discretion) and to collect safety information related to HF status and to medication consumption changes.
详细描述
Up to 30 subjects with a clinical diagnosis of Heart Failure will be enrolled in the study. It is expected that the subjects will be enrolled over a period of approximately 6 months.
3 follow up visits are planned at 2, 4 and 6 months (+/- one week) following the LINQ ICM implant.
The total expected duration of the study is of about 1 year. According to the enrolment chronological order, each subject will be allocated to Diuretic Suspension group (DS), Diuretic Increase (DI) or Diuretic+MRA medication Suspension (DMS), which will define the medication regimen before the follow-up visit.
Primary objective of the study is detecting the variation of impedance magnitude and the time of occurrence after medication regimen changes will be evaluated at each follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Clinical Diagnosis of Heart Failure
- •Plasma NT-proBNP (>250ng/L in SR and >1,000ng/L in AF)
- •LVEF <50% measured in the year before enrolment
- •Treated routinely with a daily dose of loop diuretic
- •Receiving other guideline-indicated therapy for heart failure
- •Willing to sign the informed consent form.
- •Greater than 18 years of age.
排除标准
- •Pregnant patients (all females of child-bearing potential must have a negative pregnancy test before LINQ ICM implant)
- •eGFR <30 ml/minute.
- •Any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study.
- •Patients with implanted pacemakers or defibrillators
- •Severe aortic or mitral valve disease
- •Breathlessness at rest or on minor exertion.
- •Chest pain at rest or on mild or moderate exertion.
- •Patients deemed too unstable to miss 48 hours of heart failure treatment
- •Enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager
研究组 & 干预措施
Diuretic Increase (DI)
干预措施: Diuretic Increase (DI) (Drug)
Diuretic and Medication Suspension (DMS)
干预措施: Diuretic and Medication Suspension (DMS) (Drug)
Diuretic Suspension (DS)
干预措施: Diuretic Suspension (DS) (Drug)
结局指标
主要结局
Derived-subcutaneous impedance
时间窗: 2 months
The variation of impedance magnitude and the time of occurrence after medication regimen changes will be detected by the LINQ ICM
次要结局
- Number of Transitory Arrhythmias(6 months)
- Number of Adverse Events(6 months)