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Therapy Adjustment and IndividuaLized Response With Biomarker Observation in ReaL-world Heart Failure (TAILOR-HF)

2026年6月9日 更新者:Maastricht University Medical Center

Therapy Adjustment and IndividuaLized Response With Biomarker Observation in ReaL-world Heart Failure (TAILOR-HF)

The goal of TAILOR-HF is to integrate clinical data, laboratory parameters, treatment patterns, and circulating biomarkers to identify factors that predict individual response to pharmacological treatment in patients with heart failure.

TAILOR-HF is an observational study with protocol-mandated assessments scheduled at baseline and at 1, 3, and 6 months after enrolment. Additional follow-up data will be collected through telephone visits every 6 months until the last participant has completed the protocol-mandated 6-month visit.

研究概览

研究类型

观察性的

注册 (估计的)

600

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

Patients with either de novo HF or (acute) decompensated HF who are not yet on optimal doses of guideline-recommended therapies and in whom up-titration is anticipated.

Patients will be enrolled either at the outpatient clinic of participating sites or prior to dis-charge of patients who are hospitalized for worsening HF

描述

Inclusion Criteria:

  1. Provide written and dated informed consent for participation prior to trial admission,
  2. Age ≥18 years, female or male
  3. A clinical diagnosis of new onset or worsening of heart failure with a left-ventricular ejection fraction of <50%
  4. On treatment with oral or i.v. furosemide ≥40 mg/day or equivalent (bumetanide 1mg, torasemide 10mg)
  5. Receiving <50% of the target doses of at least one of the guidelines recommended pharmacological therapies (clear intolerance not considered)
  6. Anticipated or planned uptitration

Exclusion Criteria:

  1. Scheduled or on renal replacement therapy,
  2. Clearly documented intolerance to two or more of the following groups of drugs: BB, ARNI, SGLT2i or MRAs.
  3. Diagnosis of peripartum cardiomyopathy, chemotherapy induced cardiomyopathy, current viral myocarditis, right heart failure in absence of left-sided structural disease, pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloidosis.
  4. The presence of a mechanical assist device,
  5. Scheduled for mechanical assist device or heart transplant,
  6. Current angina pectoris ≥class III,
  7. Requiring valvular surgery or revascularization in the upcoming 3 months or Coronary Artery Bypass Grafting (CABG) within the past 3 months,
  8. Anticipated need for surgery or any other cardiovascular intervention, except implantable cardioverter defibrillator and/or cardiac resynchronization therapy, within 4 weeks,
  9. Other non-cardiac conditions with limited life expectancy (≤ duration of the trial/ 1 year),
  10. Participation in another clinical trial apart from non-interventional studies.
  11. Patients with an unscheduled hospital visit or admission for reasons that are not primarily related to worsening of heart failure. Therefore, patients with concomitant pulmonary disease, even if severe, valvular disease, acute coronary syndrome or stroke, may be included when the primary diagnosis for admission to hospital or outpatient clinic visit has been heart failure, rather than the concomitant condition.
  12. Women who are pregnant, breastfeeding or those considering becoming pregnant
  13. Subjects unable to provide informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
The cohort
Patients with either de novo HF or (acute) decompensated HF who are not yet on optimal doses of guideline-recommended therapies and in whom up-titration is anticipated.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
time to death or a worsening heart failure event
大体时间:6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.
time to death or a worsening heart failure event
6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.

次要结果测量

结果测量
措施说明
大体时间
Time to cardiovascular (CV) mortality
大体时间:6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.
Time to cardiovascular (CV) mortality
6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.
Time to first (re)-hospitalization due to heart failure
大体时间:6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.
Time to first (re)-hospitalization due to heart failure
6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.
Time to all-cause hospitalization
大体时间:6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.
Time to all-cause hospitalization
6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.
Change in clinical congestion score(10) between baseline and 6 months
大体时间:6 months
change in score in 7-item Clinical Congestion Index, higher meaning more signs, based on following criteria: Orthopnea, NYHA ≥III, paroxysmal nocturnal dyspnea, hepatomegaly, peripheral pitting edema, jugular venous distension, rales
6 months
Change in QoL according to the KCCQ-CSS between baseline and 6 months
大体时间:6 months
The change in health status from baseline to 6 months will be assessed using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS). Scores range from 0 to 100, with higher scores indicating better health status, including fewer symptoms and fewer physical limitations.
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年9月1日

研究完成 (估计的)

2028年9月1日

研究注册日期

首次提交

2026年6月3日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月15日

研究记录更新

最后更新发布 (实际的)

2026年6月15日

上次提交的符合 QC 标准的更新

2026年6月9日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • TAILOR-HF
  • No 10088702 (其他赠款/资助编号:UK Research and Innovation (UKRI))
  • 101112022 (其他赠款/资助编号:Innovative Health Initiative Joint Undertaking (IHI JU))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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