Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,428
- 试验地点
- 2
- 主要终点
- Composite endpoint of hospitalization for heart failure or all-cause death (first event)
研究概览
简要总结
The purpose of the study is to assess the impact of HeartLogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device.
详细描述
The study is a pragmatic, registry-based, randomized controlled trial. Eligible patients in Denmark will be randomized 1:1 to either HeartLogic-guided management or usual care. During the trial, patients in the HeartLogic arm will be contacted by the study team in case of any HeartLogic alerts for evaluation and treatment decisions. There will be no mandatory in-person visits scheduled in the trial. HeartLogic alerts will be managed according to a prespecified management guide. Trial data besides device-related data will be retrieved from the Danish nationwide health registries including baseline information and endpoint data. The control group will receive usual HF care in the Danish health system without the involvement of the study team. The study will comply with the standards of the CONSORT statement and the principles of the Declaration of Helsinki.
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
- Single (Participant)
盲法说明
Participants will be blinded to treatment allocation. Active-arm participants will be unblinded at the time of first HeartLogic alert.
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
- •Implanted with a CRT-D or ICD device that has HeartLogic capability and ability to change HeartLogic enablement per randomization
- •Age ≥18 years
- •Compliant with remote monitoring and not listed in the LATITUDE™ remote monitoring system as "not monitored"
排除标准
- •There are no specific exclusion criteria for the trial.
研究组 & 干预措施
HeartLogic-guided management
HeartLogic alerts will be transmitted to the study team, which will subsequently contact the participant to assess any treatment needs. Treatment needs will be assessed according to current clinical practice guidelines.
干预措施: HeartLogic (Other)
Standard care
The control group will receive usual HF care in the Danish health system.
结局指标
主要结局
Composite endpoint of hospitalization for heart failure or all-cause death (first event)
时间窗: 42 months
次要结局
- All-cause mortality(42 months)
- Composite endpoint of hospitalization for heart failure or all-cause death (recurrent events)(42 months)
- All-cause hospitalization(42 months)
- Hospitalization for heart failure (first event)(42 months)
研究者
Tor Biering-Sørensen
Professor, MD, MSc, MPH, PhD, MP
Herlev and Gentofte Hospital