Heart Failure With Preserved Ejection FractionNCT04063579
Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction
A study testing Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization and Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP) in people with Heart Failure With Preserved Ejection Fraction, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a prospective study that aims to define the utility of cardiac magnetic resonance feature tracking (CMR-FT) as a non-invasive quantification tool to assess diastolic functionality in patients with Heart Failure with preserved ejection fraction. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization and Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2018to 31 Dec 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients presenting with symptoms and signs suggestive of HFpEF
- Patients undergoing coronary catheterisation for stable chest pain with no evidence of diastolic dysfunction, heart failure, infarct, left ventricular ejection fraction <50% or significant coronary artery disease (ie. >50% narrowing of one or more coronary arteries)
- Volunteers must be asymptomatic with no cardiac risk factors and no previous cardiac history
Who cannot join
- Patients suspected to have HFpEF but echocardiography and/or invasive pressure measurements do not confirm diagnosis of HFpEF.
- Significant underlying ischaemia based on clinical history and non-invasive imaging or catheter coronary angiography if indicated.
- Contraindication to CMR study
- Estimated glomerular filtration rate <30 ml/min/1.73 m2
- More than moderate valvular disease
- Severe pulmonary disease (ie. FEV1 <- 50% predicted)
- Cardiomyopathy
- Constrictive pericarditis
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective study that aims to define the utility of cardiac magnetic resonance feature tracking (CMR-FT) as a non-invasive quantification tool to assess diastolic functionality in patients with Heart Failure with preserved ejection fraction.
Read the detailed description
Despite the increasing prevalence and poor prognosis of HFpEF worldwide, it is facing diagnostic challenges due to its non-specific clinical manifestations. Currently, echocardiography serves as the main diagnostic tool, but alternatives are limited to less preferred invasive procedures in most clinical situations.
It is therefore proposed to investigate HFpEF using cardiovascular magnetic resonance imaging (CMR), as an alternative non-invasive diagnostic tool which carries lower risk than invasive procedures.
The study aims to: (1) access the utility of CMR-FT as a new indicator to diagnose diastolic dysfunction by differentiating HFpEF patients from non-HFpEF patient and normal volunteers. (2) Compare accuracy of CMR-FT to CMR tagging and phase contrast imaging.
- Being tested
- Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization, Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterizationDiagnostic test
Imaging, blood tests, LV pressure measurement
Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)Diagnostic test
Imaging and Blood tests
| Study group | Role | What they receive |
|---|---|---|
| Patients with heart failure with preserved ejection fraction | Experimental | Not described Receives: Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization |
| Non-heart failure patients | Experimental | Not described Receives: Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization |
| Normal Volunteers | Experimental | Not described Receives: Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of feature tracking diastolic strain rate to diagnose diastolic dysfunction by differentiating HFpEF patients from the non-HFpEF patients and normal volunteers
Measured: 2 years
Secondary outcomes (2)
Complication rate of cardiac catheterisation
Measured: 2 years
Unexpected findings by CMR (eg. Cardiac amyloidosis)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start1 Jun 2018
- Primary completion29 Sep 2021
- Study completion31 Dec 2021
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 Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063579
- Sponsor's protocol ID
- UW18-022
- Status last verified
- May 2023
- First submitted
- 16 Aug 2019
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ng MY, Kwan CT, Yap PM, Fung SY, Tang HS, Tse WWV, Kwan CNF, Chow YHP, Yiu NC, Lee YP, Fong AHT, Hwang S, Fong ZFW, Ren QW, Wu MZ, Wan EYF, Lee KCK, Leung CY, Li A, Montero D, Vardhanabhuti V, Hai J, Siu CW, Tse HF, Pennell DJ, Mohiaddin R, Senior R, Yiu KH. Diagnostic accuracy of cardiovascular magnetic resonance strain analysis and atrial size to identify heart failure with preserved ejection fraction. Eur Heart J Open. 2023 Mar 7;3(2):oead021. doi: 10.1093/ehjopen/oead021. eCollection 2023 Mar.
PubMed 36992915
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT04063579
- Acronym / sponsor ID
- UW18-022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Aug 2019 (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 is a prospective study that aims to define the utility of cardiac magnetic resonance feature tracking (CMR-FT) as a non-invasive quantification tool to assess diastolic functionality in patients with Heart Failure with preserved ejection fraction.
Detailed description
Despite the increasing prevalence and poor prognosis of HFpEF worldwide, it is facing diagnostic challenges due to its non-specific clinical manifestations. Currently, echocardiography serves as the main diagnostic tool, but alternatives are limited to less preferred invasive procedures in most clinical situations.
It is therefore proposed to investigate HFpEF using cardiovascular magnetic resonance imaging (CMR), as an alternative non-invasive diagnostic tool which carries lower risk than invasive procedures.
The study aims to: (1) access the utility of CMR-FT as a new indicator to diagnose diastolic dysfunction by differentiating HFpEF patients from non-HFpEF patient and normal volunteers. (2) Compare accuracy of CMR-FT to CMR tagging and phase contrast imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with heart failure with preserved ejection fraction | Experimental | Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization |
| Non-heart failure patients | Experimental | Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization |
| Normal Volunteers | Experimental | Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting with symptoms and signs suggestive of HFpEF
- Patients undergoing coronary catheterisation for stable chest pain with no evidence of diastolic dysfunction, heart failure, infarct, left ventricular ejection fraction <50% or significant coronary artery disease (ie. >50% narrowing of one or more coronary arteries)
- Volunteers must be asymptomatic with no cardiac risk factors and no previous cardiac history
Key exclusion criteria (8 listed)
- Patients suspected to have HFpEF but echocardiography and/or invasive pressure measurements do not confirm diagnosis of HFpEF.
- Significant underlying ischaemia based on clinical history and non-invasive imaging or catheter coronary angiography if indicated.
- Contraindication to CMR study
- Estimated glomerular filtration rate <30 ml/min/1.73 m2
- More than moderate valvular disease
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 |
|---|---|---|
| Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterizationImaging, blood tests, LV pressure measurement | Diagnostic test | Non-heart failure patients, Patients with heart failure with preserved ejection fraction |
| Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)Imaging and Blood tests | Diagnostic test | Normal Volunteers |
Primary outcome
Accuracy of feature tracking diastolic strain rate to diagnose diastolic dysfunction by differentiating HFpEF patients from the non-HFpEF patients and normal volunteers
Time frame: 2 years
2 secondary outcomes
Complication rate of cardiac catheterisation
Time frame: 2 years
Unexpected findings by CMR (eg. Cardiac amyloidosis)
Time frame: 2 years
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 10 May 2023.
- Results publication: PubMed 36992915Ng MY, Kwan CT, Yap PM, Fung SY, Tang HS, Tse WWV, Kwan CNF, Chow YHP, Yiu NC, Lee YP, Fong AHT, Hwang S, Fong ZFW, Ren QW, Wu MZ, Wan EYF, Lee KCK, Leung CY, Li A, Montero D, Vardhanabhuti V, Hai J, Siu CW, Tse HF, Pennell DJ, Mohiaddin R, Senior R, Yiu KH. Diagnostic accuracy of cardiovascular magnetic resonance strain analysis and atrial size to identify heart failure with preserved ejection fraction. Eur Heart J Open. 2023 Mar 7;3(2):oead021. doi: 10.1093/ehjopen/oead021. eCollection 2023 Mar.
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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?
A study testing Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization and Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP) in people with Heart Failure With Preserved Ejection Fraction, run by The University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 8 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 10 May 2023. 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 Hong Kong. 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?
Accuracy of feature tracking diastolic strain rate to diagnose diastolic dysfunction by differentiating HFpEF patients from the non-HFpEF patients and normal volunteers (time frame: 2 years). 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 NCT04063579, 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 10 May 2023.