Heart FailureNCT02791126
A Novel Automated & Comprehensive Approach for Ventricular Function Assessment in Heart Failure
An observational study of Heart Failure, run by National Heart Centre Singapore at 1 site in Singapore.
Trial summary
Heart failure is a major health care burden. It can occur with either normal or reduced LV ejection fraction, depending on different degrees of ventricular remodelling. The investigators recently published a new method, curvedness-based imaging. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiovascular Magnetic Resonance and Echocardiogram
- How many people
- 78 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2013to Aug 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic
Who may be able to join
- Patients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic.
- Written informed consent obtained
Who cannot join
- Aged < 21 years
- Contraindication to CMR examination.
- Cardiac pacemaker
- Brain aneurysm or clips
- Electronic implants or prosthesis
- Eye metal foreign body injury
Show all 13Show fewer
- Severe claustrophobia
- Severe renal impairment, glomerular filtration rate < 30ml/min/1.73m2
- Non-cardiac illness with life expectancy of less than 2 years
- Previous heart, kidney, liver or lung transplantation.
- HF primary due to severe valve disease
- Other specific subgroups of HF: Including constrictive pericarditis, complex adult congenital heart disease, hypertrophic cardiomyopathy, eosinophilic myocarditis, cardiac amyloid and acute chemotherapy-induced cardiomyopathy.
- Isolated right heart failure. Combined right and left heart failure will be included; Secondary to severe lung disease or pulmonary hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Curvedness-based Imaging: A Novel Automated & Comprehensive Approach for Ventricular Function Assessment in Heart Failure
Heart failure is a major health care burden. It can occur with either normal or reduced LV ejection fraction, depending on different degrees of ventricular remodelling. The investigators recently published a new method, curvedness-based imaging. The investigators have also reported the diagnostic utility of curvedness-based imaging in various cardiac diseases. The investigators now propose to prospectively assess curvedness-based imaging for diagnosis of heart failure with normal ejection fraction and with reduced ejection fraction, and examine left ventricular systolic and diastolic function and predicts the prognosis in a cohort of HF patients.
Read the detailed description
Heart failure imposes major global health care burden on society and suffering for the individual.In the US, HF affects 5.7 million patients, and is the leading cause of hospitalization for people over 65 years, with 25% to 50% rate or hospital readmission within 6 months.In Singapore, between 1991 and 1998, it accounted for 4.5% of all hospital admissions and 2.5% of mortality in the geriatric age group.It confers an annual mortality of 10%.
The early diagnosis and identification of the underlying etiology of HF is of paramount importance; some causes require specific treatment and may be correctable. From updated American College of Cardiology/American Heart Association guidelines, some questions must be addressed for suspected HF patients: Is the left ventricular ejection fraction preserved or reduced? Is the structure of the LV normal or abnormal? Are there other structural abnormalities such as right ventricular (RV) abnormalities that could account for the clinical presentation? Is there LV global and regional dysfunction and to what extent? Is the etiology ischemic or non-ischemic?
Cardiac imaging is important both for HF diagnosis and monitoring of progress. Impaired pump function, expressed reduced left ventricular ejection fraction is often used as a marker of HF. About 50% of HF have preserved EF.In this situation, more intricate and comprehensive imaging involving measurement of multiple diastolic and systolic parameters, usually using echocardiography, may become necessary to address the questions mentioned above.
Our solution is expected to result in a significant cost saving for HF patients. HF diagnosis is still very challenging, consisting of assessment of medical and family histories, a physical exam and diagnostic imaging tests. The investigators compare the cost difference in traditional way against our proposed solution. The traditional diagnostic tests include chest x-ray, BNP blood test, echocardiography, nuclear heart scan and cardiac catheterization. In this project, the investigators estimate the cost of echocardiography, nuclear heart scan and cardiac catheterization for HF diagnosis. Based on clinical experience, among 1000 patients undergoing echocardiography, 50% will be referred to nuclear heart scan and 30% will be referred to invasive cardiac catheterization. The cost of the whole workup is estimated to be $1.95 million. If 1000 patients undergo our proposed CBI solution directly, the cost estimated at $1.4 million. The cost saving is estimated at S$400 per patient.
Hence, the investigators will be exploring the following for this study:
Primary aim: Assess LV systolic and diastolic function from curvedness-based imaging in 120 HF patients with reduced ejection fraction and normal ejection fraction.
Secondary aim: Evaluate the utility of curvedness-based imaging for the diagnosis of etiology of HF, against gold standard gadolinium enhanced CMR in subgroup of HF patients.
Exploratory aim: Evaluate the utility of curvedness-based imaging for the prediction of prognosis during 6 month follow up, where clinical outcome include death, CV death and HF re-admission.
- Conditions
- Heart Failure
- Being tested
- Cardiovascular Magnetic Resonance, Echocardiogram
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Magnetic ResonanceOther
For the evaluation of left ventricular volumes, function and mass. This is also for the assessment of myocardial fibrosis based on delayed enhancement imaging technique.
EchocardiogramOther
For the assessment of diastolic and systolic function as well as valvular and cardiac function. Ventricular-arterial coupling will also be performed.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure | Patients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic.
Cardiovascular Magnetic Resonance and Echocardiogram will be performed. Receives: Other: Cardiovascular Magnetic Resonance; Other: Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergic reaction due to MRI contrast
Measured: Within first day of scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startNov 2013
- Primary completionAug 2017
- Study completionAug 2017
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ru San Tan, MD, Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791126
- Sponsor's protocol ID
- 2013/934/C
- Status last verified
- Sep 2017
- First submitted
- 31 May 2016
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curvedness-based Imaging: A Novel Automated & Comprehensive Approach for Ventricular Function Assessment in Heart Failure
- ClinicalTrials.gov ID
- NCT02791126
- Acronym / sponsor ID
- 2013/934/C
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 6 Jun 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.
Heart failure is a major health care burden. It can occur with either normal or reduced LV ejection fraction, depending on different degrees of ventricular remodelling. The investigators recently published a new method, curvedness-based imaging. The investigators have also reported the diagnostic utility of curvedness-based imaging in various cardiac diseases. The investigators now propose to prospectively assess curvedness-based imaging for diagnosis of heart failure with normal ejection fraction and with reduced ejection fraction, and examine left ventricular systolic and diastolic function and predicts the prognosis in a cohort of HF patients.
Detailed description
Heart failure imposes major global health care burden on society and suffering for the individual.In the US, HF affects 5.7 million patients, and is the leading cause of hospitalization for people over 65 years, with 25% to 50% rate or hospital readmission within 6 months.In Singapore, between 1991 and 1998, it accounted for 4.5% of all hospital admissions and 2.5% of mortality in the geriatric age group.It confers an annual mortality of 10%.
The early diagnosis and identification of the underlying etiology of HF is of paramount importance; some causes require specific treatment and may be correctable. From updated American College of Cardiology/American Heart Association guidelines, some questions must be addressed for suspected HF patients: Is the left ventricular ejection fraction preserved or reduced? Is the structure of the LV normal or abnormal? Are there other structural abnormalities such as right ventricular (RV) abnormalities that could account for the clinical presentation? Is there LV global and regional dysfunction and to what extent? Is the etiology ischemic or non-ischemic?
Cardiac imaging is important both for HF diagnosis and monitoring of progress. Impaired pump function, expressed reduced left ventricular ejection fraction is often used as a marker of HF. About 50% of HF have preserved EF.In this situation, more intricate and comprehensive imaging involving measurement of multiple diastolic and systolic parameters, usually using echocardiography, may become necessary to address the questions mentioned above.
Our solution is expected to result in a significant cost saving for HF patients. HF diagnosis is still very challenging, consisting of assessment of medical and family histories, a physical exam and diagnostic imaging tests. The investigators compare the cost difference in traditional way against our proposed solution. The traditional diagnostic tests include chest x-ray, BNP blood test, echocardiography, nuclear heart scan and cardiac catheterization. In this project, the investigators estimate the cost of echocardiography, nuclear heart scan and cardiac catheterization for HF diagnosis. Based on clinical experience, among 1000 patients undergoing echocardiography, 50% will be referred to nuclear heart scan and 30% will be referred to invasive cardiac catheterization. The cost of the whole workup is estimated to be $1.95 million. If 1000 patients undergo our proposed CBI solution directly, the cost estimated at $1.4 million. The cost saving is estimated at S$400 per patient.
Hence, the investigators will be exploring the following for this study:
Primary aim: Assess LV systolic and diastolic function from curvedness-based imaging in 120 HF patients with reduced ejection fraction and normal ejection fraction.
Secondary aim: Evaluate the utility of curvedness-based imaging for the diagnosis of etiology of HF, against gold standard gadolinium enhanced CMR in subgroup of HF patients.
Exploratory aim: Evaluate the utility of curvedness-based imaging for the prediction of prognosis during 6 month follow up, where clinical outcome include death, CV death and HF re-admission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure | – | Other: Cardiovascular Magnetic Resonance, Other: EchocardiogramPatients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic. Cardiovascular Magnetic Resonance and Echocardiogram will be performed. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic
Key inclusion criteria (2 listed)
- Patients presented to hospital with a primary diagnosis of Heart Failure or are attending a hospital clinic for management of Heart Failure within 6 months of an episode of decompensated heart failure, which either resulted in a hospital admission (primary diagnosis) or was treated in out-patient clinic.
- Written informed consent obtained
Key exclusion criteria (13 listed)
- Aged < 21 years
- Contraindication to CMR examination.
- Cardiac pacemaker
- Brain aneurysm or clips
- Electronic implants or prosthesis
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 |
|---|---|---|
| Cardiovascular Magnetic ResonanceFor the evaluation of left ventricular volumes, function and mass. This is also for the assessment of myocardial fibrosis based on delayed enhancement imaging technique. | Other | Heart Failure |
| EchocardiogramFor the assessment of diastolic and systolic function as well as valvular and cardiac function. Ventricular-arterial coupling will also be performed. | Other | Heart Failure |
Primary outcome
Allergic reaction due to MRI contrast
Time frame: Within first day of scan
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 5 Apr 2018.
- Individual participant dataSharing planned: No
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HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
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Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
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Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
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Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
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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.
Ru San Tan, MD principal investigator
National Heart Centre Singapore
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 National Heart Centre Singapore at 1 site in Singapore.
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 13 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 5 Apr 2018. 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 Singapore. 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?
Allergic reaction due to MRI contrast (time frame: Within first day of scan). 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 5 Apr 2018.