Assessment of the Possible Association Between Left Ventricular Diastolic Dysfunction and Carotid Atherosclerosis and Brain White Matter Damage

April 8, 2022 updated by: Giuseppe Lembo, Neuromed IRCCS
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

88

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • age ≥ 35 and ≤ 65 years
  • written informed consent

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with grade 2 and 3 LV diastolic dysfunction
Patients with high filling pressure
Other: No interventions
No interventions - observational study
Patients with normal and grade 1 LV diastolic dysfunction
Patients with normal filling pressure
Other: No interventions
No interventions - observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of white matter hyperintensities volume
Time Frame: At Enrollment
Brain MRI
At Enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of plaques and carotid atherosclerosis
Time Frame: At Enrollment
Ultrasound of the supraortic trunks
At Enrollment
Characterization of cardiac overload with blood markers
Time Frame: At Enrollment
NT-proBNP
At Enrollment
Detection of cognitive decline by decrease of MoCA score
Time Frame: At Enrollment
Cognitive tests
At Enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuromed IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2022

Primary Completion (ANTICIPATED)

October 1, 2023

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (ACTUAL)

September 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 8, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMB09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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