HemodyalysisPRE-COCONCT07608679
Estimation of the Prevalence of Microcirculatory Dysfunction in Uremic Cardiopathy Among Dialysis Patients
A study testing Transthoracic ultrasound at rest, Cardiological stress test and Coronary angiography in people with Hemodyalysis, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hemodyalysis
- What is being tested?
- Transthoracic ultrasound at rest, Cardiological stress test and Coronary angiography
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2027to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85000
Grégoire COUVRAT-DESVERGNES, gregoire.couvrat@ght85.fr
About this study
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.
- Conditions
- Hemodyalysis
- Being tested
- Transthoracic ultrasound at rest, Cardiological stress test, Coronary angiography
- Keywords
- microcirculatory disorders, hemodyalysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic ultrasound at restDiagnostic test
Transthoracic ultrasound at rest
Cardiological stress testDiagnostic test
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with microcirculatory heart disease (i.e. microvascular dysfunction or microvascular vasospasm) identified during coronary angiography
Measured: Cardiac examinations to be carried out within 8 to 10 weeks of enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study startSep 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodyalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grégoire COUVRAT-DESVERGNES, Principal investigator, Centre Hospitalier Departemental Vendee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608679
- Sponsor's protocol ID
- CHD24_0002
- Acronym
- PRE-COCO
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of the Prevalence of Microcirculatory Dysfunction in Uremic Cardiopathy Among Dialysis Patients
- ClinicalTrials.gov ID
- NCT07608679
- Acronym / sponsor ID
- PRE-COCO / CHD24_0002
- Conditions
- Hemodyalysis
- Keywords
- microcirculatory disorders, hemodyalysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- Sep 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic ultrasound at restTransthoracic ultrasound at rest | Diagnostic test | – |
| Cardiological stress testLeft to the discretion of the centre: dobutamine echocardiography or myocardial scintigraphy. | Diagnostic test | – |
| Coronary angiographyEven even if the stress test comes back normal (these tests appear to be less effective at diagnosing microcirculatory abnormalities) | Diagnostic test | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
Related trials for Hemodyalysis
Not yet recruiting
AVF-MONITOR POC Proof-of-concept Study
Hemodyalysis
RecruitingObservational study
Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients
Hemodyalysis, Kidney Tansplant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grégoire COUVRAT-DESVERGNES principal investigator
Centre Hospitalier Departemental Vendee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic ultrasound at rest, Cardiological stress test and Coronary angiography in people with Hemodyalysis, run by Centre Hospitalier Departemental Vendee at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chloé MOREAU (251446327 ext. +33, promotion.urc@chd-vendee.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.