Remote Supervision to Decrease Hospitalization Rate (RESULT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- The primary endpoint of the trial will be composite: death for any reason or hospitalization due to cardiovascular reasons.
研究概览
简要总结
Purpose: Home monitoring (HM) services supplied by different manufacturers (St Jude Medical, Biotronik, Medtronic) enables trained medical staff (doctors, electrophysiology nurses and technicians) to safely follow-up patients with implanted ICD/CRT-D remotely, with omitting unnecessary visits in outpatient clinic, shortening time to medical intervention and therefore help to decrease hospitalization rate among those patients.
The RESULT study primary endpoint of the trial will be a composite of all-cause death or hospitalization due to cardiovascular reasons.
The primary technical endpoint is to construct and evaluate a unified and integrated platform for data collected from RM devices manufactured by different companies: Carelink™ (Medtronic®, Minneapolis, MN, USA), Merlin™ (Saint Jude Medical®, St. Paul, MN, USA) and Home Monitoring™ (Biotronik®, Berlin, Germany).
详细描述
The RESULT trial is a prospective, single-center, randomized, open label, parallel study. All consecutive patients with symptomatic HF and reduced ejection fraction (≤ 35%) with ICDs or CRT-Ds implanted accordingly to current ESC practice guidelines will be prospectively randomized in a 1:1 fashion to either a traditional or an RM-based follow-up model. Six hundred patients will be enrolled. The inclusion and exclusion criteria are shown in Table 1. The clinical status of patients will be estimated using the composite endpoint of all-cause death and hospitalization due to cardiovascular reasons. The study protocol has been approved by a local ethics committee and complies with the Declaration of Helsinki. A written informed consent will be obtained from all study participants. Primary endpoint The primary endpoint of the trial will be a composite of all-cause death or hospitalization due to cardiovascular reasons. Hospitalization for cardiovascular reasons should consist of:
- Hospitalization due to progression of heart failure.
- Hospitalization due to persistent arrhythmia (AF, VT).
- Hospitalization due to embolic episode.
- Hospitalization due to acute coronary syndrome. Every patient will be followed for at least 12 months after randomization. Assessment of hospitalization events for cardiovascular reasons will be performed according to a recently published consensus [13]. The final classification of hospital admissions due to cardiovascular reasons will be made by a blinded endpoints committee. The primary technical endpoint is to construct and evaluate a unified and integrated platform for data collected from RM devices manufactured by different companies: Carelink™ (Medtronic®, Minneapolis, MN, USA), Merlin™ (Saint Jude Medical®, St. Paul, MN, USA) and Home Monitoring™ (Biotronik®, Berlin, Germany). Secondary endpoints Both elements combined in the primary endpoint will be analyzed separately to estimate their relative impact on the primary endpoint.
The secondary endpoints include the following:
- All-cause death.
- Hospitalization due to cardiovascular reasons.
- Time to medical intervention in case of relevant incidents (arrhythmic, device malfunction, signs of HF decompensation).
- Average number of visits to an outpatient clinic (scheduled and unscheduled) per patient.
- Time to first unscheduled visit in an outpatient clinic.
- Incidence of inappropriate ICD shocks.
- Proportion of visits to outpatient clinics with relevant findings (necessity of changes of device programming or pharmacological therapy, rehospitalization, interventions, invasive procedures).
- Assessment of quality of life of living study participants according to the Minnesota Quality of Life Questionnaire.
- Cost-effectiveness, defined as the cost of hospitalizations and/or scheduled and unscheduled visits in both groups.
All consecutive patients after implantation of an ICD or CRT-D manufactured by St.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •EF≤35% prior to implantation
- •Period up to 30 days after implantation (ICD/CRT-D) according to ESC guidelines
- •Agreement for telemetric supervision
- •Informed consent for clinical trial.
排除标准
- •Existence of factors that may cause risk for lack of cooperation in trial regimen (distant residence, mental illness, lack of skills in operating simple electronic devices).
- •unavailability of mobile network service in the place of residence/stay.
- •Device implanted during intravenous administration of inotropic agents.
研究组 & 干预措施
Home Monitoring
Remote monitoring od ICD/CRT-D function and patient condition. Device: HM provided by St Jude Medical, Biotronik or Medtronic.
干预措施: Home Monitoring (Device)
HM option not active.
Regular visits in outpatient clinic. Device: no HM
干预措施: no Home Monitoring (Device)
结局指标
主要结局
The primary endpoint of the trial will be composite: death for any reason or hospitalization due to cardiovascular reasons.
时间窗: 12 months
次要结局
- time to first unscheduled visit in outpatient clinic(12 months)
- proportion of visits in outpatient clinic with relevant findings (necessity of changes of device programming or pharmacological therapy, re-hospitalization, interventions, invasive procedures)(12 months)
- costs of treatment of patients with implanted ICD/CRT-D in both arms of the study (hospitalization, control visits)(12 months)
- average number of visits in outpatient clinic (scheduled and unscheduled) per patient(12 months)
- incidence of inappropriate ICD shocks(12 months)
- time to medical intervention in case of relevant incidents (arrhythmic, device malfunction, signs heart failure decompensation) in both arms of the study(12 months)
- changes in quality of life (Minnesota Quality of Life Questionnaire )(baseline and after 12 months)
研究者
Lech Polonski
Professor, PhD, MD
Silesian Centre for Heart Diseases