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This prospective single-center observational study aims to evaluate the relationship between elevated plasma homocysteine levels and early echocardiographic abnormalities in patients with newly diagnosed essential hypertension. Adult patients diagnosed with essential hypertension within the previous 6 months will undergo clinical assessment, ambulatory blood pressure monitoring, electrocardiography, laboratory testing, and comprehensive transthoracic echocardiography including diastolic function assessment and strain analysis when image quality is adequate. Participants will be classified according to plasma homocysteine level using, and patients with elevated and normal homocysteine levels will be compared with respect to diastolic dysfunction and left ventricular and left atrial global longitudinal strain parameters. Clinical, laboratory, and echocardiographic data will also be used to develop a machine-learning based model for prediction of H-type hypertension.
Hypertension may lead to subclinical myocardial dysfunction before overt structural heart disease becomes evident. Homocysteine has been associated with endothelial dysfunction, oxidative stress, vascular remodeling, and myocardial impairment. However, the association between elevated homocysteine and early diastolic dysfunction in newly diagnosed hypertensive patients has not been fully characterized.
This prospective, single-center, observational cohort study will enroll at least 500 adults with newly diagnosed essential hypertension within the preceding 6 months. Peripheral venous blood samples will be collected, and plasma homocysteine levels will be measured in batches after enrollment of a predefined number of participants. All participants will undergo standardized clinical and laboratory evaluation, ambulatory blood pressure monitoring, electrocardiography, and comprehensive transthoracic echocardiography. Echocardiographic assessment will include conventional chamber measurements, mitral inflow Doppler parameters, tissue Doppler septal and lateral e' velocities, left ventricular ejection fraction and volumes, and left ventricular and left atrial strain analysis where feasible.
Participants will be categorized into elevated homocysteine and normal homocysteine groups using a threshold of 15 µmol/L. The first-stage objective of the study is to determine whether elevated homocysteine is associated with early diastolic dysfunction and impaired ventricular and atrial longitudinal deformation in newly diagnosed hypertension. A secondary objective is to assess clinical, laboratory, and echocardiographic correlates of elevated homocysteine and to develop a machine-learning based prediction model for H-type hypertension. Long-term follow-up is planned as a future second phase of the project.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elevated Homocysteine Group | Patients with newly diagnosed essential hypertension and plasma homocysteine levels greater than 15 µmol/L. |
| |
| Normal Homocysteine Group | Patients with newly diagnosed essential hypertension and plasma homocysteine levels less than or equal to 15 µmol/L. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Homocysteine Measurement and Echocardiography | Diagnostic Test | Peripheral venous blood sampling for plasma homocysteine measurement and comprehensive transthoracic echocardiography including diastolic function assessment and strain analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Early Left Ventricular Diastolic Dysfunction | Presence of early left ventricular diastolic dysfunction based on predefined echocardiographic diastolic function criteria assessed by transthoracic echocardiography at baseline, compared between patients with elevated homocysteine levels and normal homocysteine levels. | Baseline assessment at enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Mitral Inflow Doppler E/A Ratio by Transthoracic Echocardiography | Comparison of mitral inflow Doppler E/A ratio assessed by transthoracic echocardiography between patients with elevated homocysteine levels and normal homocysteine levels at baseline. | Baseline assessment at enrollment |
| Septal Mitral Annular e' Velocity by Tissue Doppler Imaging Echocardiography |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with newly diagnosed essential hypertension evaluated at a single tertiary care center, who undergo clinical assessment, laboratory testing, ambulatory blood pressure monitoring, electrocardiography, and echocardiographic evaluation including diastolic function and strain analysis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yunus emre yavuz, MD | Contact | +90 5306069194 | +903322235976 | eyavuz@erbakan.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| yunus emre yavuz, MD | Necmettin Erbakan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Necmettin Erbakan University Meram Faculty of Medicine | Recruiting | Konya | Meram | 42080 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D020138 | Hyperhomocysteinemia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Comparison of septal mitral annular e' velocity assessed by tissue Doppler imaging echocardiography between patients with elevated homocysteine levels and normal homocysteine levels at baseline. |
| Baseline assessment at enrollment |
| Lateral Mitral Annular e' Velocity by Tissue Doppler Imaging Echocardiography | Comparison of lateral mitral annular e' velocity assessed by tissue Doppler imaging echocardiography between patients with elevated homocysteine levels and normal homocysteine levels at baseline. | Baseline assessment at enrollment |
| Average E/e' Ratio by Doppler Echocardiography | Comparison of average E/e' ratio assessed by Doppler echocardiography between patients with elevated homocysteine levels and normal homocysteine levels at baseline. | Baseline assessment at enrollment |
| Left Ventricular Global Longitudinal Strain by Speckle-Tracking Echocardiography | Comparison of left ventricular global longitudinal strain assessed by speckle-tracking echocardiography between patients with elevated homocysteine levels and normal homocysteine levels at baseline. | Baseline assessment at enrollment |
| Left Atrial Global Longitudinal Strain by Speckle-Tracking Echocardiography | Comparison of left atrial global longitudinal strain assessed by speckle-tracking echocardiography between patients with elevated homocysteine levels and normal homocysteine levels at baseline. | Baseline assessment at enrollment |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008286 | Malabsorption Syndromes |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |