Digital Solutions in Heart Therapy (DIGNITY) - a Randomized Controlled Trial Using Telemedicine for Heart Failure Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- composite guideline-directed medical therapy optimization score
研究概览
简要总结
This study aims to assess the safety and effectiveness of telemedicine guided strategy on guideline-directed medical therapy (GDMT) optimization in hospitalized patients with heart failure in comparison to usual care in Switzerland.
详细描述
Heart failure (HF) is a chronic condition affecting approximately 26 million people worldwide, with acute decompensations leading to frequent hospitalizations and increased mortality. While guideline-directed medical therapy (GDMT) has been shown to improve outcomes in HF with reduced ejection fraction (HFrEF), real-world data indicate suboptimal implementation, with delayed initiation and low adherence to target doses. The STRONG-HF study demonstrated that rapid up-titration of GDMT following hospitalization significantly reduces HF-related mortality and readmission, highlighting the importance of early and structured treatment optimization. However, close monitoring during the vulnerable post-discharge phase remains resource-intensive and difficult to implement in routine care.
The DIGNITY study aims to assess the safety and effectiveness of a telemedicine-guided strategy for optimizing GDMT in patients with HFrEF compared to usual care in Switzerland after discharge. The study hypothesizes that telemedicine-supported management will improve GDMT optimization and clinical outcomes in this high-risk patient population.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years at the time of hospital admission
- •Ability to use a (smart)phone and/or tablet for the follow-up
- •Documented left ventricular ejection fraction (LVEF) > 40% assessed within preceding 12 months
- •Not treated with optimal doses of oral HF therapies within 2 days before anticipated hospital discharge for acute HF in at least one of the medication categories (for details see Table 1 on page 10)
- •Hospitalized due to acute HF decompensation.
- •Specific measures within 24 hours prior to randomization
- •Systolic blood pressure > 100 mmHg, and heart rate > 60bpm
- •Serum potassium < 5mmol/L
排除标准
- •Inability to use a (smart)phone or tablet
- •Clear intolerance to high doses of betablockers, ACE inhibitors, or ARBs
- •Estimated glomerular filtration rate <30ml/min/1.73m2 or dialysis
- •Myocardial infarction, unstable angina or cardiac surgery within 3 months, percutaneous transluminal coronary intervention within 1 months prior to screening
- •Cardiac resynchronization therapy device implantation within 3 months prior to screening
- •Presence of significant obstructive lesion of the left ventricular outflow tract
- •Amyloid cardiomyopathy
- •Participation in other clinical trials for drugs
- •Pregnant or nursing women
- •Women of child-bearing potential who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception
结局指标
主要结局
composite guideline-directed medical therapy optimization score
时间窗: 3 month post-discharge
composite guideline-directed medical therapy (GDMT) score is defined as the sum of care optimization changes and care deoptimization changes at 3 months post discharge.
次要结局
- Proportion of heart failure(during whole study phase from randomization to 90 days post-discharge)
- Quality of life score(at randomization and 90 days post-discharge)
- Optimization score(at randomization and 90 days post-discharge)
- Patient Health Questionnaire(at randomization and 90 days post-discharge)
- Proportion of hospitalization(during whole study phase from randomization to 90 days post-discharge)
- Proportion of clinical encounters setting 1(during whole study phase from randomization to 90 days post-discharge)
- Proportion of clinical encounters setting 2(during whole study phase from randomization to 90 days post-discharge)
- Dosage of diuretics(during whole study phase from randomization to 90 days post-discharge)
- Proportion of safety issues(during whole study phase from randomization to 90 days post-discharge)