Precision Rehabilitation for Veterans With (HFpEF)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Heart Failure, Preserved Ejection Fraction. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Precision Rehabilitation for Veterans With Heart Failure With Preserved Ejection Fraction (HFpEF)
Обзор
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 oxygen delivered to the tissues during exercise. Researchers must first examine whether the facility is capable of supporting such a study and whether in a modest number of patients, there is no clear detrimental effect to exercise. Rather, there may be an important improvement that has been underestimated to date. Participation will require a time commitment for performing exercise 3 times per week for 12 weeks in addition to having a small amount of blood drawn twice. There will also be a specialized form of a stress test (cardiopulmonary exercise test; "CPET") with ultrasound imaging of the heart (echocardiography) completed twice.
Подробное описание
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 (moderate continuous training; MCT) increased VO2Peak, the quatitative measure of CRF) but not to the very aggressive level specified by the study. As such, the findings were considered statistically insignificant. To address the clinical question utilizing accepted targets, fill the scientific gaps, and advance the understanding of how monitored exercise improves both HFpEF severity and the lives of Veterans with HFpEF, an adequately powered study is required to assess the role of MCT for improving CRF, HF symptoms, QOL, physical functioning, and myocardial structure and function. Identifying patients at baseline likely to respond to MCT is the subject of the second aim and will be important for maximizing VA resources and delivering timely and effective care to veterans with HFpEF. The investigators plan to enroll 4 patients to provide preliminary and feasibility data to refine the protocol for the intended study, a request of the review committee who have favorably scored the MERIT proposal.
The long-term strategy is to improve exercise tolerance and functional capacity of HFpEF patients by favorably altering cardiac structure and function and the microRNA signature driving myocardial fibrosis. The investigators intend to conduct a larger study to test the central hypothesis that monitored exercise training improves CRF, HF symptoms, QOL, and functional status in veterans with HFpEF and that the expression pattern of miRs critical for regulating fibrosis (miR-,-21,-29,-133) can identify HFpEF patients responsive to exercise training when integrated into a comprehensive predictive tool incorporating clinical characteristics along with sensitive echocardiographic measures of LV diastolic function. This project will provide feasibility and preliminary data in 4 patients for the future study.
Первичные конечные точки
- Cardiorespiratory Fitness (CRF) [Срок оценки: 12 Weeks]
Вторичные конечные точки (6)
- Change in Kansas City Cardiomyopathy Questionnaire 12 total score [Срок оценки: From patient enrollment to program completion at 12 weeks]
- Change in 6 Minute Walk Distance (feet) [Срок оценки: From enrollment to the end of the program at 12 Weeks]
- Exercise capacity [Срок оценки: From patient enrollment to program completion at 12 weeks]
- Myocardial stiffness [Срок оценки: From patient enrollment to program completion at 12 weeks]
- Plasma MicroRNA [Срок оценки: From patient enrollment to program completion at 12 weeks]
- Physical Functioning [Срок оценки: From patient enrollment to program completion at 12 weeks]
Критерии участия
Критерии включения
- 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:
- Average E/e'>14
- Septal e'<7 cm/s or Lateral e' <10 cm/s
- TR velocity> 2.8 m/s
- LA computed volume index >34 mL/M2
- PCWP or LVEDP>15
- Ability to participate in an exercise program as determined by a research, cardiology, or primary care provider
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Columbia VA Health Care System — Columbia
Идентификаторы
NCT: NCT07493915 · 1699596 · Facility Funds