Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

NCT07480265 | Recruiting

• 1 other identifier: 2025-5720-HHT-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension (HTN); Hyperhomocysteinemia; Diastolic Dysfunction

Keywords

H-type hypertension; Homocysteine; Echocardiography; Diastolic dysfunction; Left ventricular global longitudinal strain; Left atrial global longitudinal strain; Machine learning

Outcome Measures

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.

  Baseline assessment at enrollment

Secondary Outcomes (6)

• 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

Study Arms (2)

Elevated Homocysteine Group

Patients with newly diagnosed essential hypertension and plasma homocysteine levels greater than 15 µmol/L.

Diagnostic Test: Homocysteine Measurement and Echocardiography

Normal Homocysteine Group

Patients with newly diagnosed essential hypertension and plasma homocysteine levels less than or equal to 15 µmol/L.

Diagnostic Test: Homocysteine Measurement and Echocardiography

Interventions

Homocysteine Measurement and Echocardiography DIAGNOSTIC_TEST

Peripheral venous blood sampling for plasma homocysteine measurement and comprehensive transthoracic echocardiography including diastolic function assessment and strain analysis.

Elevated Homocysteine Group; Normal Homocysteine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University Meram Faculty of Medicine

Konya, Meram, 42080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hypertension; Hyperhomocysteinemia

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• yunus emre yavuz, MD

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yunus emre yavuz, MD

CONTACT

+90 5306069194; eyavuz@erbakan.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 18, 2026
• Study Start: June 2, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

TU (1)