Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction

Conditions
-----------------
Heart Failure With Preserved Ejection Fraction

Intervention / Treatment
-----------------
* Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization
* Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with heart failure with preserved ejection fraction<br> | Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization<br>* Imaging, blood tests, LV pressure measurement<br>|
| Experimental: Non-heart failure patients<br> | Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization<br>* Imaging, blood tests, LV pressure measurement<br>|
| Experimental: Normal Volunteers<br> | Diagnostic Test: Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)<br>* Imaging and Blood tests<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of feature tracking diastolic strain rate to diagnose diastolic dysfunction by differentiating HFpEF patients from the non-HFpEF patients and normal volunteers |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate of cardiac catheterisation |  | 2 years | 
| Unexpected findings by CMR (eg. Cardiac amyloidosis) |  | 2 years |