ClinicalTrials.gg
CompletedNCT04275882Updated Mar 8, 2022

Demographical and Clinical Profile of Patients With Left Ventricular Hypertrophy

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

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
886
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Left Ventricular Hypertrophy

Keywords

  • Echocardiography
  • retrospective
  • electrocardiography
  • hypertension
  • cardiomyopathy
03

In context

Hypertrophy, Left Ventricular

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

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.

Inclusion criteria

  • Patients who have undergone / 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 form

Exclusion criteria

Exclusion Criteria:

  • Cases without optimal electro or echocardiographic examination due to limited echogenicity
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
886 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testElectrocardiogram

    There will be no new intervention performed for the patients.

    Also known as: Echocardiography

06

What researchers measure

Primary outcomes

  1. Demographic characteristics

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

    Time frame: 6 months

  2. Evaluation of etiologic data

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

    Time frame: 6 months

Other outcomes

  1. Frequency of Fabry and Amyloidosis

    Frequency of Fabry and Amyloidosis in outpatient and / or hospitalized patients with LVH

    Time frame: 6 months

07

Study locations

1 site
  • Yasemin
    Kayseri, Eyalet/Yerleşke 38000, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2020 to primary completion in Sep 2021, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 17, 2020
First posted
Feb 19, 2020
StartActual
Feb 14, 2020
Primary completionActual
Sep 1, 2021
CompletionActual
Dec 1, 2021
Last update
Mar 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04275882
Lead sponsor
Cardiovascular Academy Society, Turkey
Responsible party
Mehdi Zoghi (prof.dr., Cardiovascular Academy Society, Turkey) — Principal investigator
First posted
Feb 19, 2020
Start date
Feb 14, 2020
Primary completion
Sep 1, 2021
Completion
Dec 1, 2021
Last update
Mar 8, 2022

Study contacts

mehmet kış, dr
principal investigator · turkey

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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