Hypertension (HTN)HHT-EDDNCT07480265
Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension
An observational study of Hypertension (HTN) and Hyperhomocysteinemia, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension (HTN), Hyperhomocysteinemia, Diastolic Dysfunction
- What is being tested?
- Homocysteine Measurement and Echocardiography
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2025to Mar 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Resistant hypertension
- Secondary hypertension
- Acute coronary syndrome within the previous 6 months
- Major surgery within the previous 6 months
- Known heart failure
- Pulmonary hypertension
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Necmettin Erbakan University Meram Faculty of Medicine
Konya, Meram, 42080
YUNUS EMRE YAVUZ, MD, +905306069194, eyavuz@erbakan.edu.tr
About this study
Official title: Relationship Between Elevated Homocysteine Levels and Early Diastolic Dysfunction in Newly Diagnosed Hypertensive Patients
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.
Read the 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.
- Being tested
- Homocysteine Measurement and Echocardiography
- Keywords
- H-type hypertension, Homocysteine, Echocardiography, Diastolic dysfunction, Left ventricular global longitudinal strain, Left atrial global longitudinal strain, Machine learning
- Medical subject headings
- Hypertension, Hyperhomocysteinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homocysteine Measurement and EchocardiographyDiagnostic test
Peripheral venous blood sampling for plasma homocysteine measurement and comprehensive transthoracic echocardiography including diastolic function assessment and strain analysis.
| Study group | Role | What they receive |
|---|---|---|
| Elevated Homocysteine Group | Patients with newly diagnosed essential hypertension and plasma homocysteine levels greater than 15 µmol/L. Receives: 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. Receives: Diagnostic Test: Homocysteine Measurement and Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline assessment at enrollment
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline assessment at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start2 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yunus emre yavuz, Necmettin Erbakan University
- Investigators
- yunus emre yavuz, MD, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480265
- Sponsor's protocol ID
- 2025-5720-HHT-01
- Acronym
- HHT-EDD
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Elevated Homocysteine Levels and Early Diastolic Dysfunction in Newly Diagnosed Hypertensive Patients
- ClinicalTrials.gov ID
- NCT07480265
- Acronym / sponsor ID
- HHT-EDD / 2025-5720-HHT-01
- Keywords
- H-type hypertension, Homocysteine, Echocardiography, Diastolic dysfunction, Left ventricular global longitudinal strain, Left atrial global longitudinal strain, Machine learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elevated Homocysteine Group | – | Diagnostic Test: Homocysteine Measurement and EchocardiographyPatients with newly diagnosed essential hypertension and plasma homocysteine levels greater than 15 µmol/L. |
| Normal Homocysteine Group | – | Diagnostic Test: Homocysteine Measurement and EchocardiographyPatients with newly diagnosed essential hypertension and plasma homocysteine levels less than or equal to 15 µmol/L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Resistant hypertension
- Secondary hypertension
- Acute coronary syndrome within the previous 6 months
- Major surgery within the previous 6 months
- Known heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homocysteine Measurement and EchocardiographyPeripheral venous blood sampling for plasma homocysteine measurement and comprehensive transthoracic echocardiography including diastolic function assessment and strain analysis. | Diagnostic test | Elevated Homocysteine Group, Normal Homocysteine Group |
Primary outcome
Presence of Early Left Ventricular Diastolic Dysfunction
Time frame: 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.
6 secondary outcomes
Mitral Inflow Doppler E/A Ratio by Transthoracic Echocardiography
Time frame: Baseline assessment at enrollment
Septal Mitral Annular e' Velocity by Tissue Doppler Imaging Echocardiography
Time frame: Baseline assessment at enrollment
Lateral Mitral Annular e' Velocity by Tissue Doppler Imaging Echocardiography
Time frame: Baseline assessment at enrollment
Average E/e' Ratio by Doppler Echocardiography
Time frame: Baseline assessment at enrollment
Left Ventricular Global Longitudinal Strain by Speckle-Tracking Echocardiography
Time frame: Baseline assessment at enrollment
Left Atrial Global Longitudinal Strain by Speckle-Tracking Echocardiography
Time frame: Baseline assessment at enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
yunus emre yavuz, MD principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension (HTN) and Hyperhomocysteinemia, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yunus emre yavuz, MD (+90 5306069194 ext. +903322235976, eyavuz@erbakan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Early Left Ventricular Diastolic Dysfunction (time frame: Baseline assessment at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.