An observational study in Heart Failure With Preserved Ejection Fraction and Heart Diseases, sponsored by University of East Anglia. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-05.
Sponsored by University of East Anglia · Observational
Heart failure with preserved ejection fraction (HFpEF) is a common and growing condition with a poor prognosis but the pathophysiology and management are still being investigated. The PREFER-CMR project aims to evaluate and validate the application of novel 4D cardiac magnetic resonance flow dynamic methods to measure left ventricular pressures and validate these measurements with direct pressure measurement by coronary angiography. This is a prospective observational study of patients with HFpEF undergoing clinical evaluation with coronary angiography who will also undergo contemporaneous cardiac MRI. The primary outcome will be the level of agreement between the two methods using angiography as the reference method.
Heart failure with preserved ejection fraction (HFpEF) is prevalent, increasing in incidence and has a poor prognosis. Accurate left ventricular (LV) haemodynamic assessment is needed to diagnose and manage patients with HFpEF. The reference method for assessment is an invasive study using catheters to measure intra-ventricular pressure but this is rarely done due to its invasive nature, high procedural costs and lack of expertise, despite the fact that haemodynamic guided therapy is associated with reduced re-hospitalisation and mortality. Non-invasive methods of LV haemodynamic assessment are inaccurate. The Investigators have developed an accurate four-dimensional flow cardiac magnetic resonance (4D flow CMR) protocol which is non-invasive and addresses the issues with existing practices to evaluate HFpEF. This observational-analytical study aims to assess the utility of a non-invasive 4D flow CMR protocol for haemodynamic assessment of HFpEF, to generate clinical data to support future clinical trials, clinical translation and patient benefit. This research study will involve generating a precise haemodynamic model using invasive and non-invasive data of prospectively recruited patients. This model will be also optimised in clinical patients with arrhythmias. Also, observational data will be collected to test the model's prognostic value.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →University of East Anglia is the lead sponsor of 79 studies on the registry; 4 are open to participants now.
Compared within Heart Failure, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The extended observational arm of the study will have wider eligibility criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Suspected HFpEF group: 80 patients will be recruited with history of dyspnoea, LV ejection fraction ≥ 50%, raised NTproBNP
Diagnostic Test: Multi Parametric Cardiac Magnetic Resonance
20 patients with suspected CAD but with no dyspnoea and normal echocardiogram.
Diagnostic Test: Multi Parametric Cardiac Magnetic Resonance
Research based Cardiac MRI evaluation to determine cardiovascular haemodynamics
Left ventricular pressure measured by invasive angiography (reference method) and modelled by cardiovascular magnetic resonance imaging
Agreement of invasively measured left ventricular pressure in millimeters of mercury (mmHg) by invasive angiography to non-invasively modelled left ventricular pressure by cardiac magnetic resonance imaging. The agreement will be tested by Bland-Altman plots..
Time frame: 30 days
Prognostic relevance of left ventricular pressures measured by cardiac MRI
Is cardiovascular magnetic resonance modelled left ventricular pressure in millimeters of mercury (mmHg) associated with MACE events including re-hospitalization, stroke, myocardial infarction and death. Association between pressure measurements and MACE will be tested by Cox proportional hazards regression and Kaplan-Meier survival analysis.
Time frame: Ten years
No study locations are listed for this record.
Plan to share: Yes — The dataset of this study are available at the discretion of the Principal Investigator on reasonable request.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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University of East Anglia