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Not yet recruiting NCT07608679

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

No phase Interventional Hemodyalysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transthoracic ultrasound at rest, Cardiological stress test, Coronary angiography.
Who it may be relevant to
Registry conditions: Hemodyalysis. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

France · 1 center
  • Centre Hospitalier Départemental Vendée — La Roche-sur-Yon

Identifiers

NCT: NCT07608679 · CHD24_0002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗