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临床试验/NCT06623344
NCT06623344已完成不适用

Brain Volume and Cardiac Function in Heart Failure

Johns Hopkins University4 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
4
主要终点
Subcortical Volumes in Heart Failure

研究概览

简要总结

Patients with heart failure (HF) exhibit greater structural brain alterations and higher dementia risks than the general population. Neural atrophy in nearly every region of medical limbic circuit has been observed in HF patients. Reduction of cerebral blood flow has been suggested as the pathophysiological pathway linking HF and structural brain changes. Indeed, lower cardiac index levels were related to lower cerebral blood flow in older adults without stroke, dementia, or heart failure. A few prior studies have examined the subcortical structural differences in patients with HF compared to controls. Brain volume loss (including putamen and hippocampal volumes) have been reported in patients with low ejection fraction. Significant gray matter loss was found in specific brain regions of HF patients and included structures that serve demonstrated roles in cognitive functions. In the investigator's previous study (Comprehensive Imaging Exam of Convalesced COVID-19 Patients - COVID-19 RELATED SUBMISSION-IRB00252436), involving 100 participants (volunteers with normal heart function (ejection fraction; 50%)), the investigators observed significant correlations between thalamic volumes and ventricular stroke volumes in volunteers. Building on these findings, the investigators intend to expand the research to include individuals with heart failure (HF), employing the same MRI protocol. The study will involve obtaining a set of T1-weighted brain images to measure the volumes of seven subcortical structures. The investigators goal is to explore the relationship between subcortical volumes and cardiac parameters. Additionally, the investigators will examine whether patients with HF experience a more rapid reduction in subcortical volumes compared to those with normal cardiac function (EF;50%).

详细描述

Heart failure (HF) is a multifaceted clinical syndrome characterized by the heart's inability to effectively pump blood to meet the body's demands. This condition often results from various structural or functional cardiac disorders, impacting not only the heart but also multiple organ systems, including the brain, kidneys, lungs, and circulatory system. Patients with heart failure present a spectrum of symptoms that significantly affect quality of life, such as dyspnea and fatigue, and are typically identified by cardiac dysfunction markers like abnormal left or right ventricular filling and elevated filling pressures. Recent advances in diagnostic technologies, particularly in imaging modalities like Cardiovascular Magnetic Resonance Imaging (CMR), have opened new avenues for in-depth exploration of heart failure's underlying pathophysiology. CMR is increasingly used in heart failure management for risk stratification, viability assessment, and diagnosing conditions like myocarditis and cardiomyopathy. This technology enables detailed assessment of myocardial function, structural changes, and interactions with other organ systems. Patients with heart failure exhibit greater structural brain alterations and higher dementia risks than the general population. Neural atrophy in nearly every region of medical limbic circuit has been observed in HF patients. Initial research showed a strong correlation between thalamic volumes and ventricular stroke volumes in healthy volunteers. The investigators plan to extend this study to heart failure (HF) patients using the same MRI methods to assess the connection between subcortical brain volumes and heart health. Additionally, the investigators will explore if HF patients experience a faster decline in these brain volumes than individuals with normal heart function.

- Objectives:

Primary: To access the correlation of cardiac structure and function to the subcortical volumes in patients with heart failure.

Secondary: To compare the correlation between cardiac structure and function and subcortical volumes in heart failure patients with that in participants with normal heart function.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals with an ejection fraction (EF) below 50% who are willing to
  • provide informed consent.
  • Not claustrophobia.
  • Age: 21 years and above.
  • Ambulatory patients are eligible.

排除标准

  • Known allergy to gadolinium contrast agents
  • Metal fragments in eyes, brain, or spinal cord
  • Glomerular filtration rate (GFR) 45 mL/min (using the Cockcroft-Gault formula)
  • Pregnancy
  • Internal electrical devices, such as cochlear implant, spinal cord stimulator, pacemaker, or defibrillator
  • Presence of any other history or condition that the investigator feels would be problematic
  • Severe claustrophobia
  • Weight exceeding 300 lbs. (MRI table weight restrictions)

研究组 & 干预措施

Hospitalized

Other

Participants who were hospitalized due to heart failure (HF) illness.

干预措施: Magnetic Resonance Imaging with or without Contrast (Other)

Non-Hospitalized

Other

Participants who had heart failure (HF) but did not require hospitalization secondary to the illness.

干预措施: Magnetic Resonance Imaging with or without Contrast (Other)

结局指标

主要结局

Subcortical Volumes in Heart Failure

时间窗: From enrollment up to 30 days post treatment

To access the correlation of cardiac structure and function to the subcortical volumes in patients with heart failure.

次要结局

未报告次要终点

研究者

发起方
Johns Hopkins University
申办方类型
Other
责任方
Sponsor

研究点 (4)

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