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临床试验 NCT07493915 针对心力衰竭，Preserved Ejection Fraction目前招募中。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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Precision Rehabilitation for Veterans With (HFpEF) 4 退伍军人 运动

招募中
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临床试验NCT07493915是一项针对心力衰竭，Preserved Ejection Fraction的观察研究试验，目前试验状态为招募中。试验始于2023年6月1日，计划招募4名患者。该研究由Columbia VA Health Care System主导，预计于2026年10月9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
This study is being completed because there is conflicting information regarding the value of monitored exercise in patients with heart failure with preserved ejection fraction (HFpEF). The purpose of this study is to collect baseline information necessary for researchers to pursue a larger study evaluating how monitored exercise performed during cardiac rehabilitation may improve heart health and the amount of oxyge...显示更多
详细描述
Small studies have suggested that supervised exercise training improves cardiorespiratory fitness (CRF) in some patients with heart failure with preserved ejection fraction (HFpEF), but the response rate to exercise is broad, and the impact of exercise on quality of life and physical functioning at the Veteran level are incompletely understood. More recently, HFpEF patients randomized to moderate levels of exercise (...显示更多
官方标题

Precision Rehabilitation for Veterans With Heart Failure With Preserved Ejection Fraction (HFpEF)

疾病
心力衰竭Preserved Ejection Fraction
其他研究标识符
  • 1699596
  • Facility Funds (其他标识符) (William Jennings Bryan DORN)
NCT编号
NCT07493915
实际开始日期
2023-06-01
最近更新发布
2026-03-25
预计完成日期
2026-10-09
计划入组人数
4
研究类型
观察研究
试验状态
招募中
关键词
heart failure
preserved ejection fraction
cardiac rehab
CPET
rehabilitation
HFpEF
veterans
主要终点
结果指标度量标准描述时间框架
Cardiorespiratory Fitness (CRF)
Change in cardiorespiratory fitness response (\>10% increase in oxygen consumption on cardiopulmonary exercise testing).
12 Weeks
次要终点
结果指标度量标准描述时间框架
Change in Kansas City Cardiomyopathy Questionnaire 12 total score
Change in symptoms will be determined by assessing the difference in Kansas City Cardiomyopathy Questionnaire 12 total scores between baseline and exercise training program completion. The total score ranges from 0 to 100 with higher scores indicating better health and symptom status.
From patient enrollment to program completion at 12 weeks
Change in 6 Minute Walk Distance (feet)
Change in physical functioning using the 6-minute walk test. The change in 6 minute walking distance is expressed as an absolute value with longer distances indicating better health and physical functioning.
From enrollment to the end of the program at 12 Weeks
Exercise capacity
Change in exercise capacity in metabolic equivalents
From patient enrollment to program completion at 12 weeks
Myocardial stiffness
Change in LV myocardial and chamber stiffness by tissue doppler echocardiography
From patient enrollment to program completion at 12 weeks
Plasma MicroRNA
Change in plasma levels of miRs
From patient enrollment to program completion at 12 weeks
Physical Functioning
Change in physical functioning will be determined by assessing the difference in the summed score of questions 3-12 of the Short Form Survey (SF-36). The summed score ranges from 10-30 with higher scores indicating higher levels of physical functioning.
From patient enrollment to program completion at 12 weeks
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

  • New York Heart Association Class II or III HF symptoms

  • History of hypertension

  • EF≥50%

  • LVH confirmed by echocardiography, Cardiac CT, or Cardiac MR

  • Diastolic dysfunction which must include ≥2 of the following:

    1. Average E/e'>14
    2. Septal e'<7 cm/s or Lateral e' <10 cm/s
    3. TR velocity> 2.8 m/s
    4. LA computed volume index >34 mL/M2
    5. PCWP or LVEDP>15

  • Ability to participate in an exercise program as determined by a research, cardiology, or primary care provider

  • Ejection Fraction < 50%
  • Absence of LVH
  • LV Dilation (LV end diastolic volume indexed to BSA > 75 ml/m2)
  • Any Segmental wall motion abnormality
  • Acute ST segment elevation myocardial infarction (STEMI)
  • Significant valvular or other non-coronary heart disease
  • Any non-cardiac disease or condition that could influence myocardial function (e.g., collagen-vascular disease, history of cardiotoxic cancer chemotherapy, amyloid)
  • Anemia defined as Hgb < 11.0 g/dl in males, 10 g/dl in females
  • Current accelerating angina, unstable angina, angina at rest, or NSTEMI within 3 months
  • Chronic pulmonary disease requiring home oxygen or steroid therapy
  • Significant non-CV organ disease: Chronic hepatic or renal disease (eGFR < 25 mL/min/1.73m2)
  • Inability to provide informed consent
  • Inability to perform exercise
Columbia VA Health Care System logoColumbia VA Health Care System
William Jennings Bryan Dorn VA Medical Center logoWilliam Jennings Bryan Dorn VA Medical Center
研究责任方
Kurt Barringhaus, MD, 主要研究者, Director, Cardiac Catheterization Laboratory at WJB Dorn VAMC, Columbia, SC and PRISMA Health-Midlands, Columbia, SC; Clinical Associate Professor of Medicine, Cardiovascular Division, Palmetto Health-University of South Carolina, Columbia, SC, William Jennings Bryan Dorn VA Medical Center
研究中心联系人
联系人: Kurt Barringhaus, MD, FACC, FSCAI, 803-776-4000, [email protected]
联系人: Amy Flowers, 80-776-4000, [email protected]
1 位于 1 个国家/地区的研究中心

South Carolina

Columbia VA Health Care System, Columbia, South Carolina, 29209, United States
Kurt Barringhaus, MD, FACC, FSCAI, 联系人, 803-776-4000, [email protected]
Amy Flowers, 联系人, 803-776-4000, [email protected]
Kurt Barringhaus, MD, FACC, FSCAI, 主要研究者
招募中