Acute Decompensated Heart FailureVISCO-HFNCT06586008
The Association Between Visual Echocardiographic Scoring System and Clinical Outcomes in Patient With Acute Decompensated Heart Failure
An observational study of Acute Decompensated Heart Failure, run by Universitas Diponegoro at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Decompensated Heart Failure
- How many people
- 150 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2024to 10 Nov 2024
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 acute decompensated heart failure who fulfill eligibility criteria
Who may be able to join
- Patient with history of heart failure with reduced ejection fraction (LVEF <40%)
- Age between 18 - 70 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Dr. Kariadi Central General Hospital
Semarang, Central of Java
Leo Deddy Pradipta, +6281316499074, dancingdeagle@gmail.com
Dessy Natalia, +6281318086580, dessy.natalia88@gmail.com
About this study
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.
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- visual echocardiographic system, acute decompensated heart failure, mortality
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality within hospitalization
Measured: During hospitalization, up to 1 weeks
Secondary outcomes (2)
ICCU Length of Stay
Measured: During hospitalization, up to 1 weeks
Urine output
24 hour urine output
Measured: During hospitalization, 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 posted19 Sep 2024
- Study start1 Jan 2024
- Primary completion31 Jul 2024
- Study completion10 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Decompensated Heart FailureStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 7 Days
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
- NCT06586008
- Sponsor's protocol ID
- Undip_Kardio 3
- Acronym
- VISCO-HF
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33675942Murayama 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.
PubMed 34694368
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Visual Echocardiographic Scoring System and Clinical Outcomes in Patient With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT06586008
- Acronym / sponsor ID
- VISCO-HF / Undip_Kardio 3
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- visual echocardiographic system, acute decompensated heart failure, mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitas DiponegoroUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 10 Nov 2024 (estimated)
- First posted
- 19 Sep 2024 (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 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with acute decompensated heart failure who fulfill eligibility criteria
Key inclusion criteria (2 listed)
- Patient with history of heart failure with reduced ejection fraction (LVEF <40%)
- Age between 18 - 70 years old
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: During hospitalization, up to 1 weeks
Mortality within hospitalization
2 secondary outcomes
ICCU Length of Stay
Time frame: During hospitalization, up to 1 weeks
Urine output
Time frame: During hospitalization, up to 1 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 33675942Murayama 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.
- Background: PubMed 34694368Murayama 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.
- 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. This study is not recruiting at the moment.
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 Acute Decompensated Heart Failure, 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
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?
Mortality (time frame: During hospitalization, up to 1 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06586008, which also lists 2 linked publications.
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 19 Sep 2024.