目的:目前的心力衰竭(HF)指南建议在射血分数降低(HFrEF)的HF患者中使用四种药物。充分实施关于药物测序和及时达到目标剂量的指南指导的药物治疗(GDMT)存在明显的挑战。在日常临床实践中,如何从药物治疗的串行和顺序方法转变为四种药物的早期并行应用,这在很大程度上是未知的。以及临床医生可能不遵守新指南的原因。我们提出了现实世界中的TITRATE-HF研究的设计和基本原理,旨在评估GDMT启动的测序策略,剂量滴定模式(顺序和速度),对GDMT的不容忍,实施障碍,和患者的长期结果,慢性,恶化的HF。
结果:共4000例HFrEF患者,射血分数轻度降低的HF,射血分数改善的HF将在>40个荷兰中心登记,随访至少3年。数据收集将包括人口统计,体检和重要参数,心电图,实验室测量,超声心动图,药物,和生活质量。将收集四种GDMT药物类别的滴定步骤的详细信息。信息将包括日期,改变的主要原因,潜在的不容忍。主要临床终点是HF相关的住院治疗,HF相关的紧急访问需要静脉利尿剂,全因死亡率,和心血管死亡率。
结论:TITRATE-HF是一个真实的多中心纵向注册中心,将提供有关当代GDMT实施的独特信息,测序策略(顺序和速度),和从头预测,恶化,和慢性HF患者。
OBJECTIVE: Current heart failure (HF)
guidelines recommend to prescribe four drug classes in patients with HF with reduced ejection fraction (HFrEF). A clear challenge exists to adequately implement
guideline-directed medical therapy (GDMT) regarding the sequencing of drugs and timely reaching target dose. It is largely unknown how the paradigm shift from a serial and sequential approach for drug therapy to early parallel application of the four drug classes will be executed in daily clinical practice, as well as the reason clinicians may not adhere to new
guidelines. We present the design and rationale for the real-world TITRATE-HF study, which aims to assess sequencing strategies for GDMT initiation, dose titration patterns (order and speed), intolerance for GDMT, barriers for implementation, and long-term outcomes in patients with de novo, chronic, and worsening HF.
RESULTS: A total of 4000 patients with HFrEF, HF with mildly reduced ejection fraction, and HF with improved ejection fraction will be enrolled in >40 Dutch centres with a follow-up of at least 3 years. Data collection will include demographics, physical examination and vital parameters, electrocardiogram, laboratory measurements, echocardiogram, medication, and quality of life. Detailed information on titration steps will be collected for the four GDMT drug classes. Information will include date, primary reason for change, and potential intolerances. The primary clinical endpoints are HF-related hospitalizations, HF-related urgent visits with a need for intravenous diuretics, all-cause mortality, and cardiovascular mortality.
CONCLUSIONS: TITRATE-HF is a real-world multicentre longitudinal registry that will provide unique information on contemporary GDMT implementation, sequencing strategies (order and speed), and prognosis in de novo, worsening, and chronic HF patients.