Left Ventricular Diastolic DysfunctionNCT04549298
Assessment of the Possible Association Between Left Ventricular Diastolic Dysfunction and Carotid Atherosclerosis and Brain White Matter Damage
An observational study of Left Ventricular Diastolic Dysfunction, run by Neuromed IRCCS.
Trial summary
Left ventricular diastolic dysfunction is caused by impaired relaxation and increased left ventricular stiffness with a consequent increase in filling pressures. Currently, it is possible to classify it in 3 grades: grade 1 with normal filling pressures, grade 2 and grade 3 with high pressures. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Left Ventricular Diastolic Dysfunction
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Oct 2023
- Phase
- Observational
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be selected from patients attending the Department of AngioCardioNeurology of the IRCCS Neuromed, accordingly to the following inclusion/exclusion criteria. Approximately 88 subjects of both genders will be included in the study.
Who may be able to join
- age ≥ 35 and ≤ 65 years
- written informed consent
Who cannot join
- previous stroke or TIA
- arrhythmia or severe cardiac disease
- renal disease
- psychiatric disease
- neurological or neurodegenerative disease
- dementia
- previous carotid artery stenting or carotid surgery
- inability to be subjected MRI analysis
Trial locations and contacts
No sites are listed yet.
About this study
Left ventricular diastolic dysfunction is caused by impaired relaxation and increased left ventricular stiffness with a consequent increase in filling pressures. Currently, it is possible to classify it in 3 grades: grade 1 with normal filling pressures, grade 2 and grade 3 with high pressures. Diastolic dysfunction is closely associated with several risk factors such as hypertension, diabetes, and obesity, as well as the risk of heart failure, cardiovascular events, and death. In the field of cerebrovascular diseases, however, diastolic dysfunction is still being researched. Thus, this study aims to: 1) evaluate the white matter hyperintensities volume in association with the increase of diastolic dysfunction and filling pressures 2) evaluate the possible association with carotid atherosclerosis in case of brain damage caused by dysfunction diastolic 3) understand the mechanism of damage caused by left ventricular diastolic dysfunction on the cerebrovascular system. In order to do this, this study proposes to evaluate in a cohort of patients, between 35 and 65 years, the possible association of diastolic dysfunction with lesions on the cerebrovascular system in a future view of new marker of brain damage and new modifiable risk factor.
- Conditions
- Left Ventricular Diastolic Dysfunction
- Being tested
- No interventions
- Keywords
- Diastolic dysfunction, White matter hyperintensities, Carotid atherosclerosis
- Medical subject headings
- Ventricular Dysfunction, Left, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions - observational study
| Study group | Role | What they receive |
|---|---|---|
| Patients with grade 2 and 3 LV diastolic dysfunction | Patients with high filling pressure Receives: Other: No interventions | |
| Patients with normal and grade 1 LV diastolic dysfunction | Patients with normal filling pressure Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of white matter hyperintensities volume
Brain MRI
Measured: At Enrollment
Secondary outcomes (3)
Detection of plaques and carotid atherosclerosis
Ultrasound of the supraortic trunks
Measured: At Enrollment
Characterization of cardiac overload with blood markers
NT-proBNP
Measured: At Enrollment
Detection of cognitive decline by decrease of MoCA score
Cognitive tests
Measured: At Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Diastolic DysfunctionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Lembo, Neuromed IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549298
- Sponsor's protocol ID
- LMB09
- Status last verified
- Apr 2022
- First submitted
- 8 Sep 2020
- Last updated
- 11 Apr 2022
- 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 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Possible Association Between Left Ventricular Diastolic Dysfunction and Carotid Atherosclerosis and Brain White Matter Damage
- ClinicalTrials.gov ID
- NCT04549298
- Acronym / sponsor ID
- LMB09
- Conditions
- Left Ventricular Diastolic Dysfunction
- Keywords
- Diastolic dysfunction, White matter hyperintensities, Carotid atherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 16 Sep 2020 (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 diastolic dysfunction is caused by impaired relaxation and increased left ventricular stiffness with a consequent increase in filling pressures. Currently, it is possible to classify it in 3 grades: grade 1 with normal filling pressures, grade 2 and grade 3 with high pressures. Diastolic dysfunction is closely associated with several risk factors such as hypertension, diabetes, and obesity, as well as the risk of heart failure, cardiovascular events, and death. In the field of cerebrovascular diseases, however, diastolic dysfunction is still being researched. Thus, this study aims to: 1) evaluate the white matter hyperintensities volume in association with the increase of diastolic dysfunction and filling pressures 2) evaluate the possible association with carotid atherosclerosis in case of brain damage caused by dysfunction diastolic 3) understand the mechanism of damage caused by left ventricular diastolic dysfunction on the cerebrovascular system. In order to do this, this study proposes to evaluate in a cohort of patients, between 35 and 65 years, the possible association of diastolic dysfunction with lesions on the cerebrovascular system in a future view of new marker of brain damage and new modifiable risk factor.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with grade 2 and 3 LV diastolic dysfunction | – | Other: No interventionsPatients with high filling pressure |
| Patients with normal and grade 1 LV diastolic dysfunction | – | Other: No interventionsPatients with normal filling pressure |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from patients attending the Department of AngioCardioNeurology of the IRCCS Neuromed, accordingly to the following inclusion/exclusion criteria. Approximately 88 subjects of both genders will be included in the study.
Key inclusion criteria (2 listed)
- age ≥ 35 and ≤ 65 years
- written informed consent
Key exclusion criteria (8 listed)
- previous stroke or TIA
- arrhythmia or severe cardiac disease
- renal disease
- psychiatric disease
- neurological or neurodegenerative disease
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 |
|---|---|---|
| No interventionsNo interventions - observational study | Other | Patients with grade 2 and 3 LV diastolic dysfunction, Patients with normal and grade 1 LV diastolic dysfunction |
Primary outcome
Measurement of white matter hyperintensities volume
Time frame: At Enrollment
Brain MRI
3 secondary outcomes
Detection of plaques and carotid atherosclerosis
Time frame: At Enrollment
Characterization of cardiac overload with blood markers
Time frame: At Enrollment
Detection of cognitive decline by decrease of MoCA score
Time frame: At Enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Diastolic Dysfunction, run by Neuromed IRCCS.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Lembo, MD, PhD (+390865915225, lembo@neuromed.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of white matter hyperintensities volume (time frame: At Enrollment). 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 11 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.