Estimation of the Prevalence of Microcirculatory Dysfunct... | NCT07608679

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

NCT07608679

Sponsor

Centre Hospitalier Departemental Vendee

Status

Not yet recruiting

Last Update Posted

May 27, 2026Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Hemodyalysis

Interventions

Transthoracic ultrasound at rest
Cardiological stress test
Coronary angiography

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2027Estimated

Primary Completion Date

Jun 2028Estimated

Completion Date

Sep 2028Estimated

First Submitted Date

May 20, 2026

First Submission Date that Met QC Criteria

May 20, 2026

First Posted Date

May 27, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2026

Last Update Posted Date

May 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chloé MOREAU	Contact	251446327	+33	promotion.urc@chd-vendee.fr

Overall Officials

Name	Affiliation	Role
Grégoire COUVRAT-DESVERGNES	Centre Hospitalier Departemental Vendee	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Départemental Vendée		La Roche-sur-Yon		85000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D057791	Cardiac Imaging Techniques
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis