Heart FailureNCT04949997
Evaluation of Systolic Function in Heart Failure With Middle Ejection Fraction by 3D Speckle Tracking Imaging
An observational study of Heart Failure, run by Peking University Third Hospital at 1 site in China.
Trial summary
In 2016, the European Heart Association defined the median ejection fraction heart failure for the first time. More research is needed to improve our understanding of this population, so as to make the best clinical decision and improve the prognosis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- diagnose
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2017to 31 May 2019
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients meet the diagnostic and classification criteria of heart failure proposed in the 2016 ESC guidelines for HF but not the exclusion criteria
Who may be able to join
- Meeting the diagnostic and classification criteria of heart failure proposed in the 2016 ESC guidelines for the diagnosis and treatment of acute / chronic heart failure
Who cannot join
- acute or chronic infectious diseases;
- COPD, chronic bronchitis, emphysema and other serious lung diseases;
- Autoimmune diseases;
- Malignant tumor;
- Acute, chronic liver disease or other reasons lead to abnormal liver function (transaminase is more than 3 times of normal value);
- Acute and chronic kidney disease, end-stage renal disease (serum creatinine > 220 μmol/L, or creatinine clearance rate < 30 ml/min);
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- Heart valve disease;
- Severe arrhythmia;
- The image quality of echocardiography was poor when it was larger than three sections;
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Evaluation of Left Ventricular Systolic Function in Heart Failure With Middle Ejection Fraction by 3D Speckle Tracking Imaging
In 2016, the European Heart Association defined the median ejection fraction heart failure for the first time. More research is needed to improve our understanding of this population, so as to make the best clinical decision and improve the prognosis. In this study, 3D-STI was used to evaluate left ventricular systolic function in heart failure with median ejection fraction.
Read the detailed description
As the final manifestation of cardiovascular disease and the main cause of death, heart failure is one of the important challenges threatening human health in the 21st century. In 2016, the European Heart Association proposed a new classification standard for heart failure. In particular, for the first time, heart failure with median ejection fraction has been clearly defined. These patients have received more and more attention, but there are still relatively few studies on them. More research is needed to improve our understanding of this part of the population in order to make the best clinical decisions and improve the prognosis. 3D speckle tracking technology is a new technology developed on the basis of real-time three-dimensional echocardiography and speckle tracking technology. It is gradually recognized in the evaluation of left ventricular systolic and diastolic function, especially in the evaluation of cardiotoxicity of chemotherapy drugs. At present, the application of 3D-STI in the evaluation of left ventricular systolic function in heart failure with median ejection fraction is limited and needs further study.In this study, 3D-STI was used to evaluate left ventricular systolic function in heart failure with median ejection fraction.
- Conditions
- Heart Failure
- Being tested
- diagnose
- Keywords
- median ejection fraction, 3D-STI
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnoseOther
HF was divided into HF with preserved ejection fraction, HF with median ejection fraction and HF with reduced ejection fraction.
| Study group | Role | What they receive |
|---|---|---|
| control | patients without heart failure | |
| HF | patients with heart failure Receives: Other: diagnose |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D-STI measurement indexes
strain values of different sections from 3D-STI
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Oct 2017
- Primary completion1 Mar 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949997
- Sponsor's protocol ID
- IRB00006761-M2017152
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 2 Jul 2021
- Results posted
- 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 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Left Ventricular Systolic Function in Heart Failure With Middle Ejection Fraction by 3D Speckle Tracking Imaging
- ClinicalTrials.gov ID
- NCT04949997
- Acronym / sponsor ID
- IRB00006761-M2017152
- Conditions
- Heart Failure
- Keywords
- median ejection fraction, 3D-STI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 2 Jul 2021 (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.
In 2016, the European Heart Association defined the median ejection fraction heart failure for the first time. More research is needed to improve our understanding of this population, so as to make the best clinical decision and improve the prognosis. In this study, 3D-STI was used to evaluate left ventricular systolic function in heart failure with median ejection fraction.
Detailed description
As the final manifestation of cardiovascular disease and the main cause of death, heart failure is one of the important challenges threatening human health in the 21st century. In 2016, the European Heart Association proposed a new classification standard for heart failure. In particular, for the first time, heart failure with median ejection fraction has been clearly defined. These patients have received more and more attention, but there are still relatively few studies on them. More research is needed to improve our understanding of this part of the population in order to make the best clinical decisions and improve the prognosis. 3D speckle tracking technology is a new technology developed on the basis of real-time three-dimensional echocardiography and speckle tracking technology. It is gradually recognized in the evaluation of left ventricular systolic and diastolic function, especially in the evaluation of cardiotoxicity of chemotherapy drugs. At present, the application of 3D-STI in the evaluation of left ventricular systolic function in heart failure with median ejection fraction is limited and needs further study.In this study, 3D-STI was used to evaluate left ventricular systolic function in heart failure with median ejection fraction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | –patients without heart failure |
| HF | – | Other: diagnosepatients with heart failure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients meet the diagnostic and classification criteria of heart failure proposed in the 2016 ESC guidelines for HF but not the exclusion criteria
Key inclusion criteria (1 listed)
- Meeting the diagnostic and classification criteria of heart failure proposed in the 2016 ESC guidelines for the diagnosis and treatment of acute / chronic heart failure
Key exclusion criteria (9 listed)
- acute or chronic infectious diseases;
- COPD, chronic bronchitis, emphysema and other serious lung diseases;
- Autoimmune diseases;
- Malignant tumor;
- Acute, chronic liver disease or other reasons lead to abnormal liver function (transaminase is more than 3 times of normal value);
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 |
|---|---|---|
| diagnoseHF was divided into HF with preserved ejection fraction, HF with median ejection fraction and HF with reduced ejection fraction. | Other | HF |
Primary outcome
3D-STI measurement indexes
Time frame: one week
strain values of different sections from 3D-STI
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 Jul 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Heart Failure, run by Peking University Third Hospital at 1 site in China.
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: finished, as of the sponsor's last update on 2 Jul 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 China. 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?
3D-STI measurement indexes (time frame: one week). 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 2 Jul 2021.