NCT07480265

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Necmettin Erbakan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hypertension (HTN)
• Hyperhomocysteinemia
• Diastolic Dysfunction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Homocysteine Measurement and Echocardiography	Peripheral venous blood sampling for plasma homocysteine measurement and comprehensive transthoracic echocardiography including diastolic function assessment and strain analysis.

Timeline

• Start date: 2025-06-02
• Primary completion: 2027-12-01
• Completion: 2028-03-01
• First posted: 2026-03-18
• Last updated: 2026-03-24

Locations

1 site across 1 country: Turkey (Türkiye)