Cluster and Registry Trial Of the Working Group of Heart Failure in Denmark. Does the Strategy of Initiation of Heart Failure Medication Matter in the Real World.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16,000
- 主要终点
- Combined one year all-cause mortality or first hospitalization for worsening heart failure.
研究概览
简要总结
This study will tests whether a strategy of upfront prescription of mineralocorticoid receptor antagonists (MRA) is different from usual care, where MRA are usually prescribes as the last drug of the four drug classes used in the treatment of heart failure with reduced cardiac pump function (ace-inhibitor, beta blocker, sodium-glucose-2 inhibitors, MRA).
The study is a national study that intends to include all adult Danish patients diagnosed with heart failure and reduced pump function from early 2025 til early 2029.
Treatment strategy will be decided by randomisation, where each heart failure clinic is randomised to one of the two strategies (upfront MRA vs. usual care) for one year, followed by cross-over to the other treatment strategy for one year.
Patients will be followed according to usual care at their respective heart failure clinic. Study-specific followup will be conducted through the Danish registries for a minimum of two years.
The primary goal of the study is to evaluate whether one of the two treatment strategies leads to fewer hospitalisations for heart failure and/or death at one year after study entry.
Other goals of the study is to evaluate whether one of the two strategies leads to less kidney disease, improved quality of life and improved cost-effectiveness
详细描述
This study aims to examine whether upfront initiation of MRA followed by usual care of HFrEF medication up-titration with ACE or ARB, SGLT2 inhibitors, and beta-blockers can improve clinical outcomes compared to the usual care approach (ACEi/ARB or ARNi, BB, SGLT2i followed by MRA). The investigators hypothesize that upfront initiation of MRA may enhance adherence to MRA therapy. To test this hypothesis, a cluster randomized controlled trial will be performed comparing two strategies: [1] upfront initiation of MRA followed by usual care of up-titration of HFrEF medication versus usual car (ACEi/ARB or ARNi, BB, SGLT2i followed by MRA). This study will provide valuable insights into whether upfront initiation of MRA impacts patient outcomes, potentially leading to a shift in HFrEF management.
Methods
Design CROWD-Sequence is a cluster-randomized crossover comparative effectiveness study.
Intervention All patients will receive treatment according to national guidelines, which include all 4 pillars of modern HFrEF treatment. The intervention is only whether the heart failure clinic initiates MRA upfront at the first visit, compared with the initiation of MRA later in the up-titration of HFrEF medication.
Cluster allocation Each participating heart failure clinic will be allocated to four periods (clusters): two periods with upfront initiation of MRA followed by usual care of HFrEF medication and two periods with usual care of up-titration of HFrEF medication with initiation of MRA at a later stage. Heart failure clinics will be randomly allocated and alternate between the two strategies annually. The estimated total participation time for each heart failure clinic is four years. The randomization is unblinded. Randomization of the heart failure clinics will be performed in a 1:1 fashion. Details of randomization and allocation periods will be stored at the Sponsor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •All patients ≥18 years old who are newly diagnosed with HFrEF and allocated to an outpatient clinic for up-titration of guideline-directed medical therapy for HFrEF at participating cardiology departments
排除标准
- 未提供
研究组 & 干预措施
standard care
standard care, with physicians choice of the sequence and up-titration of heart failure medications (ACE-inhibitor, beta-blocker, mineralocorticoid receptor antagonist, SGLT2-inhibitor)
干预措施: up front use of mineralocorticoid receptor antagonist (Behavioral)
Up-front prescription of mineralocorticoid receptor antagonist, no later than the first ambulatory v
Up-front prescription of mineralocorticoid receptor antagonist, no later than the first ambulatory visit to the heart failure clinic. Earlier use during initial hospitalization is encouraged, but not mandatory
干预措施: up front use of mineralocorticoid receptor antagonist (Behavioral)
结局指标
主要结局
Combined one year all-cause mortality or first hospitalization for worsening heart failure.
时间窗: From date of enrollment until the date of first hospitalization for worsening heart failure or date of death from any cause, whichever comes first, assessed up to 200 months
次要结局
- All-cause mortality(From date of enrollment until the date of first hospitalization for worsening heart failure or date of death from any cause, whichever comes first, assessed up to 200 months)
- First hospitalization for heart failure(From date of enrollment until the date of first hospitalization for worsening heart failure or date of death from any cause, whichever comes first, assessed up to 200 months)
- Total number of acute hospitalizations(From date of enrollment until the date of first hospitalization for worsening heart failure or date of death from any cause, whichever comes first, assessed up to 200 months)
- Need for dialysis(From date of enrollment until the date of first hospitalization for worsening heart failure or date of death from any cause, whichever comes first, assessed up to 200 months)
- Change in income(From date of enrollment until the date of first hospitalization for worsening heart failure or date of death from any cause, whichever comes first, assessed up to 200 months)
研究者
Mads Jønsson Andersen
Senior Registrar, MD PhD
Aarhus University Hospital