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临床试验 NCT07493590 (CAPTURE-HFpEF) 针对射血分数保留的心力衰竭 (HFpEF)目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
CAPTURE-HFpEF: National Study of Identification and Phenotyping of Heart Failure With Preserved Ejection Fraction 30,000 生物标志物驱动 观察性
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临床试验NCT07493590 (CAPTURE-HFpEF)是一项针对射血分数保留的心力衰竭 (HFpEF)的观察研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年4月1日开始，预计招募30,000名患者。该研究由Herlev and Gentofte Hospital主导，计划于2035年4月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月25日。
简要概括
The goal of this observational study is to improve early detection, characterization, and understanding of heart failure with preserved ejection fraction (HFpEF) in adults at risk of or diagnosed with HFpEF, including men and women across Danish regions.
The main questions to answer are:
Can systematic cardiovascular screening and deep phenotyping improve early identification and classification of HFpEF?
Which cli...
显示更多详细描述
Heart failure (HF) with preserved ejection fraction (HFpEF) is a heterogeneous syndrome that will benefit from early diagnosis, extensive diagnostic work-up, and individualized therapy. HF is a global health problem and one of the leading causes of cardiovascular (CV) morbidity and mortality. While many pharmacological and interventional treatments have been developed for HF with reduced ejection fraction (HFrEF), th...显示更多
官方标题
CAPTURE-HFpEF (Cardiovascular Assessment and Phenotyping for Timely Understanding and Recognition of Evolving Heart Failure With Preserved Ejection Fraction)
疾病
射血分数保留的心力衰竭 (HFpEF)其他研究标识符
- CAPTURE-HFpEF
- H-25050340
NCT编号
实际开始日期
2026-04-01
最近更新发布
2026-03-25
预计完成日期
2035-04-01
计划入组人数
30,000
研究类型
观察研究
试验状态
尚未招募
关键词
Heart failure
Heart Failure with Preserved Ejection Fraction (HFpEF)
Cardiovascular Mortality
Cardiovascular Disease
Chronic Heart Failure
Heart Failure with Preserved Ejection Fraction (HFpEF)
Cardiovascular Mortality
Cardiovascular Disease
Chronic Heart Failure
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
不适用 | HFpEF Observational Measurements Observational measurements including collection of blood for biomarker and genetic analyses, echocardiography, ECG, and extraction of clinical data from electronic health records (comorbidities, medications, and prior hospitalizations). No treatment or procedure is assigned; all data reflect routine care and participant characteristics. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Early identification of HFpEF | Proportion (%) of individuals identified through the screening procedures outlined in the protocol among the target population. | baseline, pre-intervention |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Response, acceptance, and attendance rates | The proportion (%) of invited individuals who respond to the study invitation (response rate), the proportion (%) of responders who agree to participate (acceptance rate), and the proportion (%) of participants who attend the scheduled study visit (attendance rate). | Up to 24 months |
Barriers to participation | Reported reasons for non-participation categorized and presented as percentages among individuals declining participation. | Up to 24 months |
Patterns among non-responders | Distribution of non-responders based on educational attainment, household income, and geographic distance to the study site as indicators of socioeconomic and sociodemographic status, presented as percentages. | Up to 24 months |
Prevalence of Heart failure with preserved ejection fraction in risk factor subgroups | Prevalence (%) of HFpEF among predefined risk factor subgroups, including individuals with diabetes, hypertension, and chronic kidney disease. | Up to 24 months |
Feasibility of the logistical screening setup | Assessment of the logistical setup required to continuously examine individuals at risk for HFpEF within the study framework. | Up to 24 months |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Patients >60 years with ≥1 risk factor, OR
- Patients >50 years with ≥2 risk factors
- Hypertension
- Type 1 or 2 diabetes
- Chronic kidney disease (eGFR <60 mL/min/1.73 m²)
- Previous cardiotoxic drug exposure
- atrial fibrillation
- Ischemic heart disease
- Previous heart valve surgery/intervention
- Body mass index >30 kg/m² (self-reported)
- Use of ≥40 mg furosemide
- Obstructive sleep apnea
- Non-alcoholic fatty liver disease
- Cancer <1 year
- Dialysis
- COPD and O2
- Nursing home
- Age >90 years
- Dementia
- Known dilated cardiomyopathy
- Prior organ-transplantation
- Amyloidosis
Herlev and Gentofte Hospital研究责任方
Emil Wolsk, 主要研究者, Specialist Cardiologist, Herlev and Gentofte Hospital
没有联系数据。
1 位于 1 个国家/地区的研究中心
Herlev and Gentofte Hospital, Copenhagen, Denmark
Emil Wolsk, MD, PhD, 联系人, 38683868, [email protected]