Hypertrophic CardiomyopathyHCM-VeinNCT04129905
Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies
A study testing BNP blood sample test, Electrocardiogram and Holter ECG in people with Hypertrophic Cardiomyopathy and Endothelial Dysfunction, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Left ventricular obstruction is an invalidating complication of hypertrophic cardiomyopathies (HCM), and endothelial dysfunction has also been observed in these pathologies. However, the relation between obstruction and endothelial and venous dysfunctions has not been previously studied. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Cardiomyopathy, Endothelial Dysfunction
- What is being tested?
- BNP blood sample test, Electrocardiogram and Holter ECG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2019to 14 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients and volunteers:
- Adults (age ≥18 years), male or female,
- For female in age, efficient contraception will be required and a negative pregnancy test will be required,
- Signed informed consent form will required for each included subject after having read the information note,
- Affiliated to the national social security system,
- Patients:
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- .Patients diagnosed to have HCM secondary to sarcomeric mutation or to Fabry disease, symptomatic (dyspnea on exertion and/or chest pains during exercise),
- Healthy volunteers:
- Subjects without known cardiac disease,
- No smokers.
Who cannot join
- Patients and volunteers:
- No cardiac pathology reducing life expectancy to less than 12 months (cancer),
- Unbalanced arterial hypertension (systolic >160 mmHg and/or diastolic >120 mmHg),
- Pregnancy or breastfeeding,
- Major obesity > 140 kg,
- Impossibility or refusal to give or sign the consent form,
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- Subject in period of exclusion relative to an other protocol,
- Subject deprived of liberty by judicial or administrative decision,
- Major protected by the Law
- Patients:
- Atrial fibrillation at the time of inclusion
- Valvulopathy with severity greater than moderate.
Trial locations and contacts
1 site in 1 country.
About this study
Left ventricular obstruction is an invalidating complication of hypertrophic cardiomyopathies (HCM), and endothelial dysfunction has also been observed in these pathologies. However, the relation between obstruction and endothelial and venous dysfunctions has not been previously studied.
The main objective is to investigate the relations between endothelial and venous dysfunctions and symptomatic left ventricular outflow-tract obstruction in HCM patients.
Read the detailed description
Hypertrophic cardiomyopathies (HCM) secondary to sarcomeric gene mutation or to Anderson-Fabry disease can be complicated by left ventricular (LV) outflow-tract obstruction responsible of disabling exercise symptoms. LV outflow-tract obstruction is a complex, multifactorial and dynamical phenomenon influenced by the degree of LV hypertrophy but also by mitral valve elongation and hemodynamical components including venous return (LV preload). The clinical and research team of Dr Réant, responsible of the Bordeaux Competence Center in hereditary or rare Cardiomyopathies, has recently demonstrated that LV outflow-tract obstruction can also be influenced by the conditions of realization of exercise echocardiography tests (position: upright versus supine, type: bicycle versus treadmill), and by an abnormal venous return capacity. In parallel, it has also been demonstrated, by other research teams, that HCM can be associated to endothelial and microvascular peripheral dysfunctions. However, to date, the relation between these two elements, and with sudden cardiac death risk, have not been previously studied.
The tests which will be performed during normal recommended follow-up of the HCM patients will be: Brain Natriuretic Peptide (BNP) blood sample test, electrocardiogram (ECG), Holter ECG, echocardiography at rest and during exercise.
The tests realized in addition will be:
- air venous plethysmography: non invasive, and non painful test evaluating different parameters of venous filling by inflation of an armband around the leg, upright positioning, flexion-extension of the leg. Total duration estimated at 30-45 minutes.
- upper member arterial Doppler echography with analysis of Flow Mediated Dilatation (FMD) : measurement of the evolution of brachial artery diameter before and after inflation of a armband during 5 minutes. Non invasive and non painful test, duration 30 minutes..
- endothelial function biomarkers: blood sample test, 5 minutes. No follow-up is required for this study.
- Being tested
- BNP blood sample test, Electrocardiogram, Holter ECG, Echocardiography, Air venous plethysmography
- Keywords
- Hypertrophic Cardiomyopathy, Endothelial Dysfunction, Venous return, Left ventricular outflow-tract obstruction, Sudden cardiac death risk
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Ventricular Outflow Obstruction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNP blood sample testBiological
Performed during normal recommended follow-up of the HCM patients.
ElectrocardiogramDiagnostic test
Performed during normal recommended follow-up of the HCM patients.
Holter ECGDiagnostic test
Performed during normal recommended follow-up of the HCM patients.
EchocardiographyDiagnostic test
Performed during normal recommended follow-up of the HCM patients. Echocardiography at rest and during exercise.
Air venous plethysmographyDiagnostic test
Performed specifically for the research. Non invasive, and non painful test evaluating different parameters of venous filling by inflation of an armband around the leg, upright positioning, flexion-extension of the leg. Total duration estimated at 30-45 minute.
Upper member arterial Doppler echography with analysis of FMDDiagnostic test
Performed specifically for the research. Measurement of the evolution of brachial artery diameter before and after inflation of a armband during 5 minutes. Non invasive and non painful test, duration 30 minutes.
Endothelial function biomarkersBiological
Performed specifically for the research. Blood sample test, 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic HCM patients | Experimental | 30 subjects (25-26 sarcomeric, 4-5 Fabry). Receives: Biological: BNP blood sample test; Diagnostic Test: Electrocardiogram; Diagnostic Test: Holter ECG; Diagnostic Test: Echocardiography; Diagnostic Test: Air venous plethysmography; Diagnostic Test: Upper member arterial Doppler echography with analysis of FMD; Biological: Endothelial function biomarkers |
| Healthy controls subjects | Active comparator | 10 subjects (matched in age and sex to HCM patients) to obtain reference values of endothelial dysfunction. Receives: Diagnostic Test: Air venous plethysmography; Diagnostic Test: Upper member arterial Doppler echography with analysis of FMD; Biological: Endothelial function biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the venous ejection fraction
Via a plethysmography exam. The venous ejection fraction is measured in percentage.
Measured: Day 0
Assessment of the caliber variation of the brachial artery
Via a recording of arterial Doppler echography with analysis of FMD parameters. This parameter is measured in percentage.
Measured: Day 0
Measure of the Willebrand factor
The analysis of this biomarker of endothelial function is performed via a peripheral venous sample.
This biomarker is measured in percentage.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start22 Oct 2019
- Primary completion14 Dec 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Fédération Française de Cardiologie, Fondation Bordeaux Université, Amicus Therapeutics
- Responsible party
- Sponsor
- Investigators
- Patricia REANT, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129905
- Sponsor's protocol ID
- CHUBX 2018/04
- Other IDs
- 2019-A00192-55
- Acronym
- HCM-Vein
- Status last verified
- Feb 2022
- First submitted
- 12 Jun 2019
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies
- ClinicalTrials.gov ID
- NCT04129905
- Acronym / sponsor ID
- HCM-Vein / CHUBX 2018/04
- Keywords
- Hypertrophic Cardiomyopathy, Endothelial Dysfunction, Venous return, Left ventricular outflow-tract obstruction, Sudden cardiac death risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Fédération Française de Cardiologie, Fondation Bordeaux Université, Amicus Therapeutics
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 17 Oct 2019 (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.
Left ventricular obstruction is an invalidating complication of hypertrophic cardiomyopathies (HCM), and endothelial dysfunction has also been observed in these pathologies. However, the relation between obstruction and endothelial and venous dysfunctions has not been previously studied.
The main objective is to investigate the relations between endothelial and venous dysfunctions and symptomatic left ventricular outflow-tract obstruction in HCM patients.
Detailed description
Hypertrophic cardiomyopathies (HCM) secondary to sarcomeric gene mutation or to Anderson-Fabry disease can be complicated by left ventricular (LV) outflow-tract obstruction responsible of disabling exercise symptoms. LV outflow-tract obstruction is a complex, multifactorial and dynamical phenomenon influenced by the degree of LV hypertrophy but also by mitral valve elongation and hemodynamical components including venous return (LV preload). The clinical and research team of Dr Réant, responsible of the Bordeaux Competence Center in hereditary or rare Cardiomyopathies, has recently demonstrated that LV outflow-tract obstruction can also be influenced by the conditions of realization of exercise echocardiography tests (position: upright versus supine, type: bicycle versus treadmill), and by an abnormal venous return capacity. In parallel, it has also been demonstrated, by other research teams, that HCM can be associated to endothelial and microvascular peripheral dysfunctions. However, to date, the relation between these two elements, and with sudden cardiac death risk, have not been previously studied.
The tests which will be performed during normal recommended follow-up of the HCM patients will be: Brain Natriuretic Peptide (BNP) blood sample test, electrocardiogram (ECG), Holter ECG, echocardiography at rest and during exercise.
The tests realized in addition will be:
- air venous plethysmography: non invasive, and non painful test evaluating different parameters of venous filling by inflation of an armband around the leg, upright positioning, flexion-extension of the leg. Total duration estimated at 30-45 minutes.
- upper member arterial Doppler echography with analysis of Flow Mediated Dilatation (FMD) : measurement of the evolution of brachial artery diameter before and after inflation of a armband during 5 minutes. Non invasive and non painful test, duration 30 minutes..
- endothelial function biomarkers: blood sample test, 5 minutes. No follow-up is required for this study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic HCM patients | Experimental | Biological: BNP blood sample test, Diagnostic Test: Electrocardiogram, Diagnostic Test: Holter ECG, Diagnostic Test: Echocardiography, Diagnostic Test: Air venous plethysmography, Diagnostic Test: Upper member arterial Doppler echography with analysis of FMD, Biological: Endothelial function biomarkers30 subjects (25-26 sarcomeric, 4-5 Fabry). |
| Healthy controls subjects | Active comparator | Diagnostic Test: Air venous plethysmography, Diagnostic Test: Upper member arterial Doppler echography with analysis of FMD, Biological: Endothelial function biomarkers10 subjects (matched in age and sex to HCM patients) to obtain reference values of endothelial dysfunction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients and volunteers:
- Patients:
- .Patients diagnosed to have HCM secondary to sarcomeric mutation or to Fabry disease, symptomatic (dyspnea on exertion and/or chest pains during exercise),
- Healthy volunteers:
Key exclusion criteria (12 listed)
- Patients and volunteers:
- Patients:
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 |
|---|---|---|
| BNP blood sample testPerformed during normal recommended follow-up of the HCM patients. | Biological | Symptomatic HCM patients |
| ElectrocardiogramPerformed during normal recommended follow-up of the HCM patients. | Diagnostic test | Symptomatic HCM patients |
| Holter ECGPerformed during normal recommended follow-up of the HCM patients. | Diagnostic test | Symptomatic HCM patients |
| EchocardiographyPerformed during normal recommended follow-up of the HCM patients. Echocardiography at rest and during exercise. | Diagnostic test | Symptomatic HCM patients |
| Air venous plethysmographyPerformed specifically for the research. Non invasive, and non painful test evaluating different parameters of venous filling by inflation of an armband around the leg, upright positioning, flexion-extension of the leg. Total duration estimated at 30-45 minute. | Diagnostic test | Healthy controls subjects, Symptomatic HCM patients |
| Upper member arterial Doppler echography with analysis of FMDPerformed specifically for the research. Measurement of the evolution of brachial artery diameter before and after inflation of a armband during 5 minutes. Non invasive and non painful test, duration 30 minutes. | Diagnostic test | Healthy controls subjects, Symptomatic HCM patients |
| Endothelial function biomarkersPerformed specifically for the research. Blood sample test, 5 minutes. | Biological | Healthy controls subjects, Symptomatic HCM patients |
Primary outcome
Assessment of the venous ejection fraction
Time frame: Day 0
Via a plethysmography exam. The venous ejection fraction is measured in percentage.
Assessment of the caliber variation of the brachial artery
Time frame: Day 0
Via a recording of arterial Doppler echography with analysis of FMD parameters. This parameter is measured in percentage.
Measure of the Willebrand factor
Time frame: Day 0
The analysis of this biomarker of endothelial function is performed via a peripheral venous sample. This biomarker is measured in percentage.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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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. This study is not recruiting at the moment.
Patricia REANT, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BNP blood sample test, Electrocardiogram and Holter ECG in people with Hypertrophic Cardiomyopathy and Endothelial Dysfunction, run by University Hospital, Bordeaux 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 10 inclusion and 12 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: finished, as of the sponsor's last update on 1 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the venous ejection fraction (time frame: Day 0). The study lists 3 primary outcomes in all. 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 1 Jun 2026.