NCT06586008

Brief Summary

This study aims to evaluate the association between visual echocardiographic scoring system (visual mitral and tricuspid = VMT score) with clinical outcome among patients with acute decompensated heart failure. Researchers will collect information based on hospital registry as secondary data of in patient who had diagnosed as acute decompensated heart failure. The data consist of demographic data, clinical presentation, laboratory, and echocardiographic result were collected from hospital registry by reviewing medical record and echocardiographic machine database. 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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

September 3, 2024

Last Update Submit

September 3, 2024

Conditions

Keywords

visual echocardiographic systemacute decompensated heart failuremortality

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality within hospitalization

    During hospitalization, up to 1 weeks

Secondary Outcomes (2)

  • ICCU Length of Stay

    During hospitalization, up to 1 weeks

  • Urine output

    During hospitalization, up to 1 weeks

Eligibility Criteria

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

Patient with acute decompensated heart failure who fulfill eligibility criteria

You may qualify if:

  • Patient with history of heart failure with reduced ejection fraction (LVEF \<40%)
  • Age between 18 - 70 years old

You may not qualify if:

  • Patient with pulmonary hypertension
  • Patient with acute de novo heart failure (e.g. due to acute coronary syndrome)
  • Significant valvular heart disease (more than moderate regurgitation or more than mild stenosis)
  • Prior valve replacement/repair
  • Patient with congenital heart disease
  • Patient with pericardial disease
  • Patient with poor echocardiographic images

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Kariadi Central General Hospital

Semarang, Central of Java, Indonesia

RECRUITING

Related Publications (2)

  • Murayama M, Iwano H, Nishino H, Tsujinaga S, Nakabachi M, Yokoyama S, Aiba M, Okada K, Kaga S, Sarashina M, Chiba Y, Ishizaka S, Motoi K, Nishida M, Shibuya H, Kamiya K, Nagai T, Anzai T. Simple Two-Dimensional Echocardiographic Scoring System for the Estimation of Left Ventricular Filling Pressure. J Am Soc Echocardiogr. 2021 Jul;34(7):723-734. doi: 10.1016/j.echo.2021.02.013. Epub 2021 Mar 3.

    PMID: 33675942BACKGROUND
  • Murayama M, Iwano H, Obokata M, Harada T, Omote K, Kagami K, Tsujinaga S, Chiba Y, Ishizaka S, Motoi K, Tamaki Y, Aoyagi H, Nakabachi M, Nishino H, Yokoyama S, Tanemura A, Okada K, Kaga S, Nishida M, Nagai T, Kurabayashi M, Anzai T. Visual echocardiographic scoring system of the left ventricular filling pressure and outcomes of heart failure with preserved ejection fraction. Eur Heart J Cardiovasc Imaging. 2022 Apr 18;23(5):616-626. doi: 10.1093/ehjci/jeab208.

    PMID: 34694368BACKGROUND

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
7 Days
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

September 3, 2024

First Posted

September 19, 2024

Study Start

January 1, 2024

Primary Completion

July 31, 2024

Study Completion

November 10, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations