Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04275882 |
| Other study ID # |
LVH-TR |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 14, 2020 |
| Est. completion date |
December 1, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Cardiovascular Academy Society, Turkey |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
