An observational study in Hypertension (HTN), Hyperhomocysteinemia and Diastolic Dysfunction, sponsored by Necmettin Erbakan University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Necmettin Erbakan University · Observational
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 500 is above the median of 350 across 1,163 observational studies indexed under Hypertension.
Browse Hypertension studies →Necmettin Erbakan University is the lead sponsor of 201 studies on the registry; 48 are open to participants now.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with newly diagnosed essential hypertension and plasma homocysteine levels greater than 15 µmol/L.
Diagnostic Test: Homocysteine Measurement and Echocardiography
Patients with newly diagnosed essential hypertension and plasma homocysteine levels less than or equal to 15 µmol/L.
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.
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.
Time frame: Baseline assessment at enrollment
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.
Time frame: Baseline assessment at enrollment
Septal Mitral Annular e' Velocity by Tissue Doppler Imaging Echocardiography
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline assessment at enrollment
Plan to share: Undecided
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Started Jun 2025 (actual). Primary completion is estimated for Dec 2027, 30 months after the start.
Of 345 non-industry observational studies under Hypertension, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 111. This study's planned 30 months is below that.
Counting every sponsor, half of 426 studies reached it within 38 months; a quarter within 17 and three quarters within 96.
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