HypertensionVANESSANCT06779513
Validation and Assessment of Novel Morphology-Voltage-P-wave Score for Diagnosing Left Ventricular Diastolic Dysfunction in Patients With Hypertension
An observational study of Hypertension, run by Universitas Diponegoro at 1 site in Indonesia.
Trial summary
This study aimed to assess and validate the diagnostic utility of a novel Morphology-Voltage-P-wave Score (MVP Score) in identifying left ventricular diastolic dysfunction among patients with hypertension. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Echocardiohraphy
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2024to 15 Mar 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with essential hypertension who came to out hospital
Who may be able to join
- Essential hypertension
Who cannot join
- Secondary or resistant hypertension
- LVEF<55%
- Congenital heart disease
- Infiltrative cardiomyopathy
- Coronary artery disease
- Chronic kidney disease
Show all 9Show fewer
- Valvular heart disease
- Bundle branch block
- Arrhythmia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Dr. Kariadi Central General Hospital
Semarang, Central of Java
Leo Deddy Pradipta, +6281316499074, dancingdeagle@gmail.com
About this study
This study aimed to assess and validate the diagnostic utility of a novel Morphology-Voltage-P-wave Score (MVP Score) in identifying left ventricular diastolic dysfunction among patients with hypertension.
Researchers will collect information of patient with hypertension and underwent transthoracal echocardiography assessment. The data consist of demographic data, clinical presentation, laboratory, and echocardiography result were collected by two investigators. Then, the data was analyzed by using IBM SPSS Statistics v26.
- Conditions
- Hypertension
- Being tested
- Echocardiohraphy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiohraphyDiagnostic test
Transthoracal echocardiography for diastolic function assessment
| Study group | Role | What they receive |
|---|---|---|
| Patient with LVDD | Investigators will assess MVP score by reviewing patient 12-lead ECG. Furthermore, the MVP score will be analyzed with echocardiography result. Receives: Diagnostic Test: Echocardiohraphy | |
| Patient without LVDD | Investigators will assess MVP score by reviewing patient 12-lead ECG. Furthermore, the MVP score will be analyzed with echocardiography result. Receives: Diagnostic Test: Echocardiohraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastolic Dysfunction
Diastolic Dysfunction found in transthoracal echocardiography assessment
Measured: Up to 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Diponegoro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sodiqur Rifqi, Universitas Diponegoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779513
- Sponsor's protocol ID
- Undip_Kardio 4
- Acronym
- VANESSA
- Status last verified
- Jan 2025
- First submitted
- 11 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Assessment of Novel Morphology-Voltage-P-wave Score for Diagnosing Left Ventricular Diastolic Dysfunction in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT06779513
- Acronym / sponsor ID
- VANESSA / Undip_Kardio 4
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitas DiponegoroUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 16 Jan 2025 (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 study aimed to assess and validate the diagnostic utility of a novel Morphology-Voltage-P-wave Score (MVP Score) in identifying left ventricular diastolic dysfunction among patients with hypertension.
Researchers will collect information of patient with hypertension and underwent transthoracal echocardiography assessment. The data consist of demographic data, clinical presentation, laboratory, and echocardiography result were collected by two investigators. Then, the data was analyzed by using IBM SPSS Statistics v26.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with LVDD | – | Diagnostic Test: EchocardiohraphyInvestigators will assess MVP score by reviewing patient 12-lead ECG. Furthermore, the MVP score will be analyzed with echocardiography result. |
| Patient without LVDD | – | Diagnostic Test: EchocardiohraphyInvestigators will assess MVP score by reviewing patient 12-lead ECG. Furthermore, the MVP score will be analyzed with echocardiography result. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with essential hypertension who came to out hospital
Key inclusion criteria (1 listed)
- Essential hypertension
Key exclusion criteria (9 listed)
- Secondary or resistant hypertension
- LVEF<55%
- Congenital heart disease
- Infiltrative cardiomyopathy
- Coronary artery disease
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 |
|---|---|---|
| EchocardiohraphyTransthoracal echocardiography for diastolic function assessment | Diagnostic test | Patient with LVDD, Patient without LVDD |
Primary outcome
Diastolic Dysfunction
Time frame: Up to 1 weeks
Diastolic Dysfunction found in transthoracal echocardiography assessment
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 16 Jan 2025.
- Individual participant dataSharing planned: No
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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.
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, run by Universitas Diponegoro at 1 site in Indonesia.
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 1 inclusion and 9 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 16 Jan 2025. 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 Indonesia. 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 Leo Deddy Pradipta (+6281316499074, dancingdeagle@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diastolic Dysfunction (time frame: Up to 1 weeks). 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 16 Jan 2025.