Chronic Heart FailureNCT02725151
Acute Heart Failure Monitoring Via Inferior Vena Cava Ultrasound
An observational study of Chronic Heart Failure, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Known before diagnosed heart failure and used diuretic therapy patients will be admitted in this study.The objective of this work is whether the Inferior Vena Cava Ultrasound can be used for management of Acute Heart failure therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Heart Failure
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2015to Jan 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients constitute the study population that was admitted to emergency department with complaint of dyspnea.These patients will be accepted for this study, that known Heart Failure and must be taken diuretic therapy because of volume overload.
Who may be able to join
- Adult patients (> 18 years of age) of both sexes)
- Non-trauma patients
- Non- pregnant patients
- All patients will be accepted for this study, that known Heart Failure and must be taken diuretic therapy because of volume overload
Who cannot join
- Cardiac tamponade
- Aortic dissection
- Patients who had suffered cardiopulmonary arrest or been intubated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Inferior Vena Cava in Emergency Treatment of Acute Decompensated Heart Failure and Deciding Hospitalization
Known before diagnosed heart failure and used diuretic therapy patients will be admitted in this study.The objective of this work is whether the Inferior Vena Cava Ultrasound can be used for management of Acute Heart failure therapy. And investigators will calculation correlation of extracted urine amount with Inferior Vena Cava diameter change. Researchers will not interfere to standard recommended treatment protocol, researchers will correlated the urine amount and changed vital signs with therapy with Vena cava inferior diameter.
- Conditions
- Chronic Heart Failure
- Keywords
- inferior vena cava ultrasound, acute, heart failure, management, decompensation
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Vena cava inferior diameter change end of each 500cc urination
Measured: Maximum 3 hours
Secondary outcomes (1)
Vena cava inferior diameter change with classic treatment at each hour
Measured: Maximum 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Yamanoğlu, Haseki Training and Research Hospital
- Investigators
- Adnan Yamanoğlu, MD, Principal investigator, Haseki Training and Research Hospital, Emergency Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725151
- Sponsor's protocol ID
- 231
- Status last verified
- Feb 2021
- First submitted
- 20 Mar 2016
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Already in the nearest congress will be shared as an oral presentation or poster
Publications
Yamanoglu A, Celebi Yamanoglu NG, Ozturk S, Cakmak S, Akay S, Akyol PY, Sogut O. The value of the inferior vena cava ultrasound in the decision to hospitalise in patients with acute decompensated heart failure; the best sonographic measurement method? Acta Cardiol. 2021 May;76(3):245-257. doi: 10.1080/00015385.2020.1740422. Epub 2020 Mar 19.
PubMed 32189575
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Inferior Vena Cava in Emergency Treatment of Acute Decompensated Heart Failure and Deciding Hospitalization
- ClinicalTrials.gov ID
- NCT02725151
- Acronym / sponsor ID
- 231
- Conditions
- Chronic Heart Failure
- Keywords
- inferior vena cava ultrasound, acute, heart failure, management, decompensation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 31 Mar 2016 (estimated)
- 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.
Known before diagnosed heart failure and used diuretic therapy patients will be admitted in this study.The objective of this work is whether the Inferior Vena Cava Ultrasound can be used for management of Acute Heart failure therapy. And investigators will calculation correlation of extracted urine amount with Inferior Vena Cava diameter change. Researchers will not interfere to standard recommended treatment protocol, researchers will correlated the urine amount and changed vital signs with therapy with Vena cava inferior diameter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients constitute the study population that was admitted to emergency department with complaint of dyspnea.These patients will be accepted for this study, that known Heart Failure and must be taken diuretic therapy because of volume overload.
Key inclusion criteria (4 listed)
- Adult patients (> 18 years of age) of both sexes)
- Non-trauma patients
- Non- pregnant patients
- All patients will be accepted for this study, that known Heart Failure and must be taken diuretic therapy because of volume overload
Key exclusion criteria (3 listed)
- Cardiac tamponade
- Aortic dissection
- Patients who had suffered cardiopulmonary arrest or been intubated
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
Vena cava inferior diameter change end of each 500cc urination
Time frame: Maximum 3 hours
1 secondary outcome
Vena cava inferior diameter change with classic treatment at each hour
Time frame: Maximum 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Derived from this study: PubMed 32189575Yamanoglu A, Celebi Yamanoglu NG, Ozturk S, Cakmak S, Akay S, Akyol PY, Sogut O. The value of the inferior vena cava ultrasound in the decision to hospitalise in patients with acute decompensated heart failure; the best sonographic measurement method? Acta Cardiol. 2021 May;76(3):245-257. doi: 10.1080/00015385.2020.1740422. Epub 2020 Mar 19.
- Individual participant dataSharing planned: No. Already in the nearest congress will be shared as an oral presentation or poster
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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.
Adnan Yamanoğlu, MD principal investigator
Haseki Training and Research Hospital, Emergency Department
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 Chronic Heart Failure, run by Haseki Training and Research Hospital 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 3 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: finished, as of the sponsor's last update on 2 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vena cava inferior diameter change end of each 500cc urination (time frame: Maximum 3 hours). 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 NCT02725151, which also lists 1 linked publication.
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 2 Mar 2021.