NCT07608679

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Sep 2027

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2027

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 20, 2026

Last Update Submit

May 20, 2026

Conditions

Keywords

microcirculatory disordershemodyalysis

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with microcirculatory heart disease (i.e. microvascular dysfunction or microvascular vasospasm) identified during coronary angiography

    Cardiac examinations to be carried out within 8 to 10 weeks of enrolment

Interventions

Transthoracic ultrasound at rest

Left to the discretion of the centre: dobutamine echocardiography or myocardial scintigraphy.

Coronary angiographyDIAGNOSTIC_TEST

Even even if the stress test comes back normal (these tests appear to be less effective at diagnosing microcirculatory abnormalities)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, 85000, France

Location

MeSH Terms

Interventions

Coronary Angiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAngiographyRadiographyDiagnostic Techniques, CardiovascularHeart Function Tests

Study Officials

  • Grégoire COUVRAT-DESVERGNES

    Centre Hospitalier Departemental Vendee

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2026

First Posted

May 27, 2026

Study Start (Estimated)

September 1, 2027

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

May 27, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations