Estimation of the Prevalence of Microcirculatory Dysfunction in Uremic Cardiopathy Among Dialysis Patients

Обзор

Patients with end-stage renal disease have a high burden of cardiovascular mortality, yet ischemic heart disease is often asymptomatic and difficult to diagnose in this population. Recent data suggest that microvascular coronary dysfunction may contribute significantly to myocardial ischemia in dialysis patients, but its true prevalence remains unknown. This study aims to evaluate microcirculatory coronary impairment in hemodialysis patients using invasive coronary angiography with measurement of coronary flow reserve (CFR), index of microcirculatory resistance (IMR). The study will also describe the clinical and biological characteristics associated with microvascular dysfunction in this population, in order to better understand the mechanisms of uremic cardiomyopathy and improve cardiovascular risk stratification.

Вмешательства

• Диагностический тест Transthoracic ultrasound at rest
  Transthoracic ultrasound at rest
• Диагностический тест Cardiological stress test
  Left to the discretion of the centre: dobutamine echocardiography or myocardial scintigraphy.
• Диагностический тест Coronary angiography
  Even even if the stress test comes back normal (these tests appear to be less effective at diagnosing microcirculatory abnormalities)

Первичные конечные точки

• Percentage of patients with microcirculatory heart disease (i.e. microvascular dysfunction or microvascular vasospasm) identified during coronary angiography [Срок оценки: Cardiac examinations to be carried out within 8 to 10 weeks of enrolment]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Patients who have been on haemodialysis for at least 6 months
• Elevated troponin levels > 40 ng/L in a sample taken whilst the patient was in a stable condition, dated within the last 3 months
• Patients capable of understanding the protocol and who have given their written informed consent to participate in the research
• Patients registered with the National Health Service or eligible for it

Критерии исключения

• Age > 90 years
• Patient undergoing daily home haemodialysis
• Symptomatic stage 3 or 4 peripheral arterial disease
• Severe hypertrophic cardiomyopathy (genetic or amyloid)
• Severe valvular heart disease leading to left ventricular remodelling (surgically contraindicated severe aortic stenosis, severe mitral regurgitation, severe aortic regurgitation)
• Hospitalisation for decompensation/acute heart failure within the last month
• Acute coronary syndrome and any coronary artery disease requiring angioplasty and/or stent implantation within the last 3 months
• Contraindication to METHERGIN and DOBUTAMINE
• Patients participating in another clinical research protocol that may affect the research objectives
• Patients already included in the study
• Patients under guardianship, curatorship or deprived of their liberty
• Patients under an activated future protection order
• Patients under family authorisation
• Patient under judicial protection
• Pregnant patient

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Франция · 1 центр

• Centre Hospitalier Départemental Vendée — La Roche-sur-Yon

Идентификаторы

NCT: NCT07608679 · CHD24_0002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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