NCT07480265 Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension
| NCT ID | NCT07480265 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Necmettin Erbakan University |
| Condition | Hypertension (HTN) |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-06-02 |
| Primary Completion | 2027-12 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 years or older * Newly diagnosed essential hypertension within the previous 6 months * Ability and willingness to provide informed consent * Availability for clinical evaluation, laboratory testing, ambulatory blood pressure monitoring, electrocardiography, and transthoracic echocardiography Exclusion Criteria: * Resistant hypertension * Secondary hypertension * Acute coronary syndrome within the previous 6 months * Major surgery within the previous 6 months * Known heart failure * Pulmonary hypertension * Congenital heart disease * Atrial fibrillation or atrial flutter * Moderate or severe valvular heart disease * Chronic kidney disease * Anemia * Current folate, vitamin B12, or vitamin B6 supplementation or treatment * Inadequate echocardiographic image quality for strain analysis * Known systemic conditions that may significantly affect plasma homocysteine levels