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).
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.
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.
- Conditions
- Left Ventricular Hypertrophy
- 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.
Demographic characteristics
Demographic characteristics of patients with left ventricular hypertrophy (LVH) on ECG and / or echocardiography
Measured: 6 months
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.
- First posted19 Feb 2020
- Study start14 Feb 2020
- Primary completion1 Sep 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cardiovascular Academy Society, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Zoghi, Cardiovascular Academy Society, Turkey
- Investigators
- mehmet kış, dr, Principal investigator, turkey
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04275882
- Acronym / sponsor ID
- LVH-TR
- Conditions
- Left Ventricular Hypertrophy
- Keywords
- Echocardiography, retrospective, electrocardiography, hypertension, cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 886 participants (actual)
- Lead sponsor
- Cardiovascular Academy Society, TurkeyUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Cases without optimal electro or echocardiographic examination due to limited echogenicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrocardiogramAlso: EchocardiographyThere will be no new intervention performed for the patients. | Diagnostic test | – |
Primary outcome
Demographic characteristics
Time frame: 6 months
Demographic characteristics of patients with left ventricular hypertrophy (LVH) on ECG and / or echocardiography
Evaluation of etiologic data
Time frame: 6 months
Evaluation of etiologic data of patients with left ventricular hypertrophy (LVH) on ECG and / or Echocardiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Left Ventricular Hypertrophy
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
Not yet recruiting
Therapeutic Implications of CMR Low Native T1 in Non-treated Non-hypertrophic Females With Fabry Disease (FD)
Fabry Disease
RecruitingPhase 2
A Gene Therapy Study of RP-A501 in Male Patients With Danon Disease
Danon Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mehmet kış, dr principal investigator
turkey
1 site in 1 country: see every site and its status.
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.