Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNecmettin Erbakan University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Resistant hypertension
Secondary hypertension
Acute coronary syndrome within the previous 6 months
Major surgery within the previous 6 months
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Homocysteine Measurement and Echocardiography
Diagnostic testPeripheral venous blood sampling for plasma homocysteine measurement and comprehensive transthoracic echocardiography including diastolic function assessment and strain analysis.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Elevated Homocysteine Group1 intervention
Group B: Normal Homocysteine Group1 intervention
Trial outcomes
Primary outcomes
1
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 enrollmentSecondary outcomes
1
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 enrollment2
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 enrollment3
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 enrollment4
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 enrollmentSponsors and contacts
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Source ClinicalTrials.gov