Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

Официальное название

Relationship Between Elevated Homocysteine Levels and Early Diastolic Dysfunction in Newly Diagnosed Hypertensive Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Homocysteine Measurement and Echocardiography
  Peripheral venous blood sampling for plasma homocysteine measurement and comprehensive transthoracic echocardiography including diastolic function assessment and strain analysis.

Первичные конечные точки

• Presence of Early Left Ventricular Diastolic Dysfunction [Срок оценки: Baseline assessment at enrollment]

Вторичные конечные точки (6)

• Mitral Inflow Doppler E/A Ratio by Transthoracic Echocardiography [Срок оценки: Baseline assessment at enrollment]
• Septal Mitral Annular e' Velocity by Tissue Doppler Imaging Echocardiography [Срок оценки: Baseline assessment at enrollment]
• Lateral Mitral Annular e' Velocity by Tissue Doppler Imaging Echocardiography [Срок оценки: Baseline assessment at enrollment]
• Average E/e' Ratio by Doppler Echocardiography [Срок оценки: Baseline assessment at enrollment]
• Left Ventricular Global Longitudinal Strain by Speckle-Tracking Echocardiography [Срок оценки: Baseline assessment at enrollment]
• Left Atrial Global Longitudinal Strain by Speckle-Tracking Echocardiography [Срок оценки: Baseline assessment at enrollment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Necmettin Erbakan University Meram Faculty of Medicine — Konya

Идентификаторы

NCT: NCT07480265 · 2025-5720-HHT-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗