Relationship Between Elevated Homocysteine Levels and Early Diastolic Dysfunction in Newly Diagnosed Hypertensive Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Presence of Early Left Ventricular Diastolic Dysfunction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Elevated Homocysteine Group
Patients with newly diagnosed essential hypertension and plasma homocysteine levels greater than 15 µmol/L.
干预措施: Homocysteine Measurement and Echocardiography (Diagnostic Test)
Normal Homocysteine Group
Patients with newly diagnosed essential hypertension and plasma homocysteine levels less than or equal to 15 µmol/L.
干预措施: Homocysteine Measurement and Echocardiography (Diagnostic Test)
结局指标
主要结局
Presence of Early Left Ventricular Diastolic Dysfunction
时间窗: Baseline assessment at enrollment
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.
次要结局
- Mitral Inflow Doppler E/A Ratio by Transthoracic Echocardiography(Baseline assessment at enrollment)
- Septal Mitral Annular e' Velocity by Tissue Doppler Imaging Echocardiography(Baseline assessment at enrollment)
- Lateral Mitral Annular e' Velocity by Tissue Doppler Imaging Echocardiography(Baseline assessment at enrollment)
- Average E/e' Ratio by Doppler Echocardiography(Baseline assessment at enrollment)
- Left Ventricular Global Longitudinal Strain by Speckle-Tracking Echocardiography(Baseline assessment at enrollment)
- Left Atrial Global Longitudinal Strain by Speckle-Tracking Echocardiography(Baseline assessment at enrollment)
研究者
yunus emre yavuz
Principal Investigator
Necmettin Erbakan University
