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Right Ventricle AbnormalityNCT03900208

The Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia

An observational study of Right Ventricle Abnormality, run by University of Campania Luigi Vanvitelli.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The arrhythmogenic right ventricular cardiomyopathy, also known as arrhythmogenic right ventricular dysplasia (ARVC/D) is a rare myocardial disease with a prevalence estimated to range from 1 case on 5000 persons in the general population. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Right Ventricle Abnormality
What is being tested?
Hystological analysis of ventricular tissue
How many people
10 participants
Where
No sites listed yet
Study dates
1 Jan 2017to 1 Jan 2019
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 18 to 75 years
  • All sexes
  • Adult, Older adult

Study population: Study population of bot sexes subjetcs aged more than 18 and less than 75 years, with diagnosis of right ventricle dysplasia (RVD), and linked worse prognosis with clinicla event of fatal death. All patients will receive an autopsy and an histopathological diagnosis of RVD as major study inclusion criteria.

Who may be able to join

  • fatal cases of cardiac deaths
  • both sexes
  • aged more than 18 years and less than 75 years.

Who cannot join

  • aged less than 18 years and more than 75 years
  • patients without hystological diagnosis of right ventricle dysplasia.

About this study

Official title: The Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia From Real World Autoptic Data: Diagnosis in the Absence of Clinical Criteria

The arrhythmogenic right ventricular cardiomyopathy, also known as arrhythmogenic right ventricular dysplasia (ARVC/D) is a rare myocardial disease with a prevalence estimated to range from 1 case on 5000 persons in the general population. It have a dominant genetic transmission characterized by alterations of desmosomial proteins and predominantly affects the right ventricle. The morphological alteration of the myocardium characterized by fibro-fatty substitution predisposes to arrhythmic events that can be fatal and cause death especially in young people and athletes. International guidelines provide a classification that includes clinical and histological criteria for diagnosis based on fibrous tissue substitution, percentage and right ventricle localization. Indeed, it is mainly affected the right ventricle but in some cases also the left ventricle result involved and the fatty tissue or fibro-fatty tissue with particular arrangement may affect the full-thickness wall are pathognomonic. Authors identified 10 cases of arrhythmogenic cardiomyopathy in forensic autopsy collocated in the 2003 to 2017, included 8 males and 2 females. Their age ranged from 16 to 45 years with an average age of 28.8±8.1 years. However, authors would like to demonstrate that with ARVC/D cannot be include only cases with increased fibrosis and exclusive localization to the right ventricle nor even cases with electrocardiographic alterations and other evident clinical criteria. Indeed, in the analyzed cases authors observed an amount of fibrosis often less than the percentage reported in the literature and an involvement not only of the right ventricle but also of the septum and associated sinister ventricular modifications. To this must be added that the cases of death did not have a sudden death of relatives in family history as described in guidelines and therefore this criterion is not reliable for the purpose of a classification.

Read the detailed description

The arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVC/D), have a prevalence estimated that range from 1 case on 5000 subjects in the general population to 1 in 2000 in some European countries such as Italy and Germany. It is a rare myocardial disease, with a dominant genetic transmission characterized by alterations of desmosomial proteins including desmoplakin (DSP), plakophilin 2 (PKP2), desmoglein 2 (DSG2), and desmocollin 2 (DSC2). ARVC/D mainly affects the right ventricle but in some cases also the left ventricle result involved and the fatty tissue or fibro-fatty tissue with particular arrangement may affect the full-thickness wall are pathognomonic. Progressive loss of right ventricular myocardium and its replacement by fibro-fatty tissue is the pathological hallmark of the disease and predisposes to the early onset of arrhythmias and sudden death especially in young people and athletes. The diagnosis is difficult and based on clinical major/minor criteria, including histological aspects based on fibrous tissue substitution (in percentage) and right ventricle localization. The introduction of the new term "borderline" ARVC allows to inform those individuals with undefined diseases for minor abnormalities that are at risk and require regular follow-up.

The histological criteria consist on microscopic observation of seven fields in five areas of the myocardium at a high magnification (40x) with the support of histochemical stains for the fibrous connective tissue and for the adipose tissue. Several studies have attempted to quantify the presence of adipose and fibrous tissue in the myocardial wall, and the value for histological diagnosis of ARVC provides a minimum 3% of adipose tissue and more than 40% of fibrous tissue. Conversely, other authors have suggested that a percentage of adipose tissue ranging from 5 to 20% is suspicious. This approach had limitations due to the lack of sensitivity of many of the criteria. Particularly, in ARVC families disease-causing mutation carriers often have very insidious results that do not usually lead to a diagnosis of ARVC in clinical practice. However, in te present research authors would demonstrated that with ARVC/D cannot be included only cases with increased fibrosis and exclusive localization to the right ventricle nor even cases with electrocardiographic alterations and other evident clinical criteria. The primary study goal of reviewing the guidelines will be reducing the dependence on subjective criteria to evaluate ventricular structure and function and to incorporating cardiac magnetic resonance and genetic analysis data. In the new system, patients should be diagnosed with "defined" ARVC if they have two major criteria, 1 major and 2 minor criteria, or 4 minor criteria of different categories and "borderline" ARVC with 1 major and 1 minor criteria, or 3 minors of different categories.

Materials and methods Patients and samples Authors will assay heart sections from 10 fatal cases of death, with an average age of 28.8±8.1 years (age ranged from 16 to 45 years), defined according to commonly accepted criteria and collected from January 2003 to December 2017 at the University of Naples Federico II. All the autopsies will be performed according to the Guidelines for autopsy investigation developed by the Association for European Cardiovascular Pathology, and in all cases they will be completely examined by macroscopic autopsy.

Histological evaluation In all cases, the sampling of ventricles, atria and septum including conduction system for the heart will be performed. The original tissues samples will be fixed in 10% neutral buffered formalin and embedded in paraffin blocks. Sections (4μm thick) will be stained with hematoxylin and eosin stain (H\&E) for diagnosis. After diagnosis, sections of the representative heart tissue will be stained with a PicroSirius Red/Fast Green for fibrosis evaluation. All stained samples will be examined under digital and light microscope. Beside the location of adipose/fibrous tissue in the right or left ventricles and in the septum, seven high magnification fields (40x) will be evaluated in five regions of the myocardium.

Being tested
Hystological analysis of ventricular tissue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hystological analysis of ventricular tissueDiagnostic test

    Sections (4μm thick) will be stained with hematoxylin and eosin stain (H\&E) for diagnosis. After diagnosis, sections of the representative heart tissue will be stained with a PicroSirius Red/Fast Green for fibrosis evaluation. All stained samples will be examined under digital and light microscope. Beside the location of adipose/fibrous tissue in the right or left ventricles and in the septum, seven high magnification fields (40x) will be evaluated in five regions of the myocardium.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To measure the degree of fibrotic/fatty tissue alterations of right ventricle in patients with sudden unexplained death diagnosis.

    Authors will measure the percentage of fibrotic/fatty tissue alterations of right ventricle from human samples .

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2019
  2. Study start1 Jan 2017
  3. Primary completion1 Jan 2018
  4. Study completion1 Jan 2019

Resources

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
Cohort
Time perspective
Prospective
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03900208
Sponsor's protocol ID
SecondUNI 28.03.2019
Status last verified
Apr 2019
First submitted
28 Mar 2019
Last updated
4 Apr 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Right Ventricle Abnormality, run by University of Campania Luigi Vanvitelli.

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 3 inclusion and 2 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 4 Apr 2019. 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?

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?

To measure the degree of fibrotic/fatty tissue alterations of right ventricle in patients with sudden unexplained death diagnosis. (time frame: 12 months). 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 4 Apr 2019.

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