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Left Ventricular HypertrophyNCT04275882

Demographical and Clinical Profile of Patients With Left Ventricular Hypertrophy

An observational study of Left Ventricular Hypertrophy, run by Cardiovascular Academy Society, Turkey at 1 site in Turkey (Türkiye).

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

Left ventricular hypertrophy (LVH) is the most common result of the heart trying to pump blood against the high afterload, as in hypertension and aortic stenosis.Although hypertension is the most common cause of LVH, LVH can also be found in athletes and cardiomyopathies or in storage disorders such as amyloidosis. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Left Ventricular Hypertrophy
What is being tested?
Electrocardiogram
How many people
886 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 Feb 2020to 1 Dec 2021
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted to cardiology clinics and / or outpatient clinics with left ventricular hypertrophy (LVH) detected by ECG and / or echocardiography will be included retrospectively.

Who may be able to join

  • Patients who have undergone ECG / ECO within the last 6 months and have been found to meet LVH according to the specified criteria
  • older than 18 years and younger than 90 years
  • who signed the informed consent form

Who cannot join

  • Cases without optimal electro or echocardiographic examination due to limited echogenicity

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Yasemin

    Kayseri, Eyalet/Yerleşke, 38000

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Retrospective Demographic, Clinical and Etiologic Data of Patients Presenting to Cardiology Clinic and / or Outpatient Clinics With Left Ventricular Hypertrophy Detected by Electrocardiography and/or Echocardiography: LVH-TR

Left ventricular hypertrophy (LVH) is the most common result of the heart trying to pump blood against the high afterload, as in hypertension and aortic stenosis.Although hypertension is the most common cause of LVH, LVH can also be found in athletes and cardiomyopathies or in storage disorders such as amyloidosis. In addition, genetic diseases also play an important role in the pathogenesis of LVH. Fabry disease is another disease that should be considered in patients with left ventricular hypertrophy.Left ventricular hypertrophy is a common and potentially modifiable cardiovascular risk factor that is frequently overlooked in clinical practice.The benefit of combining ECG and echocardiography in the diagnosis of LVH has been demonstrated.Early diagnosis and treatment-related regression of LVH, reduces adverse cardiovascular events and improves survival.Therefore, the investigators planned to perform a retrospective, observational LVH-TR study in order to determine the etiologic causes of LVH, the symptoms presented by the patients, and the effects of patients' demographic characteristics on LVH.

Read the detailed description

Left ventricular hypertrophy (LVH) is an abnormal increase in the mass of the left ventricular (LV) myocardium caused by a chronic increased workload in the heart.This is most common result of the heart trying to pump blood against the high afterload, as in hypertension and aortic stenosis.Although hypertension is the most common cause of LVH, LVH can also be found in athletes and cardiomyopathies or in storage disorders such as amyloidosis. In addition, genetic diseases also play an important role in the pathogenesis of LVH. Fabry's disease is an X-linked lysosomal storage disorder caused by mutations in the gene encoding galactosidase A. In a study in which 47 patients analyzed, the prevalence of Fabry disease was found to be 2.1% in patients with LVH.Since enzyme replacement therapy is important for Fabry patients, early and accurate diagnosis is very important.Amyloidosis is another disease that should be considered in patients with left ventricular hypertrophy.It should be considered especially in patients with preserved ejection fraction heart failure, in patients over 60 years of age, in men with ventricular hypertrophy, and in case of incompatibility between left ventricular thickness and QRS voltage. In the THAOS study, symptoms and signs of cardiac involvement were found in 42.1% of patients with TTR amyloidosis. In a study that included of 3287 patients, the prevalence of LVH was 14.9% in men and 9.1% in women.LVH increases cardiovascular mortality and morbidity, so the etiology of LVH is extremely important to determine the method of treatment of patients and improve survival.Data from the Framingham Heart Study show that the presence of LVH diagnosed by ECG, X-ray, or echocardiography is associated with a 3-fold increased risk for CV events and 5 to 9-fold increased risk for sudden cardiac death.A meta-analysis based on 10 studies with 27,000 patients showed that LVH was associated with an increased risk of supraventricular and ventricular arrhythmias.The incidence of supraventricular tachycardia was 11.1% in patients with LVH and 1.1% in patients without LVH. The incidence of ventricular arrhythmia (tachycardia and fibrillation) was 5.5% in patients with LVH and 1.2% in patients without LVH.Several studies have shown that the risk of atrial fibrillation increases with LVH.As shown in the Framingham Heart Study, patients with atrial fibrillation are 5 times more likely to have a stroke and the mortality rate has increased by 1.5-1.9.

LVH can be detected by electrocardiography (ECG), echocardiography (ECHO) or cardiac magnetic resonance imaging (CMRI). Each has its own advantages and disadvantages.Among these tests ECG is the cheapest and easiest to diagnose LVH. Its specificity is acceptably high, but its sensitivity is low.Although ECG is not sensitive and is not used to rule out LVH, it still has a role in the diagnosis and management of LVH. The best-known electrocardiographic criteria for the diagnosis of LVH are the Cornell product and the Sokolow-Lyon index. Another preferred test for evaluating LVH is echocardiography. ECHO is much more sensitive than ECG, and it can also detect other abnormalities such as left ventricular dysfunction and valve disease. In this test, the left ventricular end-diastolic diameter, posterior wall thickness and interventricular septum thickness can be measured, and in addition to these measurements the left ventricular mass index can be calculated from the patient's height and weight.The benefit of combining ECG and ECHO to identify LVH has been documented. Patients with LVH on both ECG and ECHO have a particularly high risk of heart failure and hospitalization, so this indicating the importance of combining different methods for LVH assessment.

Being tested
Electrocardiogram
Keywords
Echocardiography, retrospective, electrocardiography, hypertension, cardiomyopathy
Medical subject headings
Hypertrophy, Left Ventricular, Hypertension, Cardiomyopathies

What participants receive

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

  • ElectrocardiogramDiagnostic test

    Also called Echocardiography

    There will be no new intervention performed for the patients.

What is being measured

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

  1. Demographic characteristics

    Demographic characteristics of patients with left ventricular hypertrophy (LVH) on ECG and / or echocardiography

    Measured: 6 months

  2. Evaluation of etiologic data

    Evaluation of etiologic data of patients with left ventricular hypertrophy (LVH) on ECG and / or Echocardiography

    Measured: 6 months

Timeline

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

  1. First posted19 Feb 2020
  2. Study start14 Feb 2020
  3. Primary completion1 Sep 2021
  4. Study completion1 Dec 2021

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
Retrospective
Enrolment
886 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04275882
Sponsor's protocol ID
LVH-TR
Status last verified
Aug 2021
First submitted
17 Feb 2020
Last updated
8 Mar 2022
Results posted
No
Data monitoring committee
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 Left Ventricular Hypertrophy, run by Cardiovascular Academy Society, Turkey at 1 site in Turkey (Türkiye).

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 1 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 8 Mar 2022. 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 Turkey (Türkiye). 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?

Demographic characteristics (time frame: 6 months). The study lists 2 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 8 Mar 2022.

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