NCT06779513

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

January 11, 2025

Last Update Submit

January 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diastolic Dysfunction

    Diastolic Dysfunction found in transthoracal echocardiography assessment

    Up to 1 weeks

Study Arms (2)

Patient with LVDD

Investigators will assess MVP score by reviewing patient 12-lead ECG. Furthermore, the MVP score will be analyzed with echocardiography result.

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.

Diagnostic Test: Echocardiohraphy

Interventions

EchocardiohraphyDIAGNOSTIC_TEST

Transthoracal echocardiography for diastolic function assessment

Patient with LVDDPatient without LVDD

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with essential hypertension who came to out hospital

You may qualify if:

  • Essential hypertension

You may not qualify if:

  • Secondary or resistant hypertension
  • LVEF\<55%
  • Congenital heart disease
  • Infiltrative cardiomyopathy
  • Coronary artery disease
  • Chronic kidney disease
  • Valvular heart disease
  • Bundle branch block
  • Arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Kariadi Central General Hospital

Semarang, Central of Java, Indonesia

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Leo Deddy Pradipta

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; Former of Head of Department of Cardiovascular Medicine Faculty of Medicine Universitas Diponegoro

Study Record Dates

First Submitted

January 11, 2025

First Posted

January 16, 2025

Study Start

January 1, 2024

Primary Completion

December 31, 2024

Study Completion

March 15, 2025

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations