An observational study in Left Ventricular Hypertrophy, sponsored by Cardiovascular Academy Society, Turkey. Completed at 1 site in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-03-08.
Sponsored by Cardiovascular Academy Society, Turkey · Observational
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.
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.
162 studies on the registry are indexed under Hypertrophy, Left Ventricular; 28 are open to participants now.
This study's enrollment of 886 is above the median of 198 across 60 observational studies indexed under Hypertrophy, Left Ventricular.
Browse Hypertrophy, Left Ventricular studies →Cardiovascular Academy Society, Turkey is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients admitted to cardiology clinics and / or outpatient clinics with left ventricular hypertrophy (LVH) detected by ECG and / or echocardiography will be included retrospectively.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
There will be no new intervention performed for the patients.
Also known as: Echocardiography
Demographic characteristics
Demographic characteristics of patients with left ventricular hypertrophy (LVH) on ECG and / or echocardiography
Time frame: 6 months
Evaluation of etiologic data
Evaluation of etiologic data of patients with left ventricular hypertrophy (LVH) on ECG and / or Echocardiography
Time frame: 6 months
Frequency of Fabry and Amyloidosis
Frequency of Fabry and Amyloidosis in outpatient and / or hospitalized patients with LVH
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Feb 2020 to primary completion in Sep 2021, 18 months.
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Hypertrophy, Left Ventricular →
Cardiovascular Academy Society, Turkey