NCT04275882

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
886

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 8, 2022

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

February 17, 2020

Last Update Submit

March 7, 2022

Conditions

Keywords

Echocardiographyretrospectiveelectrocardiographyhypertensioncardiomyopathy

Outcome Measures

Primary Outcomes (2)

  • Demographic characteristics

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

    6 months

  • Evaluation of etiologic data

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

    6 months

Other Outcomes (1)

  • Frequency of Fabry and Amyloidosis

    6 months

Interventions

ElectrocardiogramDIAGNOSTIC_TEST

There will be no new intervention performed for the patients.

Also known as: Echocardiography

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasemin

Kayseri, Eyalet/Yerleşke, 38000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertrophy, Left VentricularHypertensionCardiomyopathies

Interventions

ElectrocardiographyEchocardiography

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsVascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisCardiac Imaging TechniquesDiagnostic ImagingUltrasonography

Study Officials

  • mehmet kış, dr

    turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof.dr.

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 19, 2020

Study Start

February 14, 2020

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

March 8, 2022

Record last verified: 2021-08

Locations