Left Ventricular Stiffness vs. Fibrosis Quantification by T1 Mapping in Heart Failure With Preserved Ejection Fraction

Study Overview
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Brief Summary
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StiffMAP-HFpEF trial is an investigator initiated, observational, single-center study that will evaluate whether fibrosis quantification by cardiac MRI correlates with left and right ventricular stiffness derived from pressure-volume analysis, aiming to clarify if cardiac MRI is a valid, non-invasive method to assess diastolic function in patients with Heart Failure with preserved ejection fraction.

Detailed Description
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Heart Failure with preserved ejection fraction (HFpEF) and diastolic dysfunction is a growing medical challenge. To date almost every second patient with heart failure has a preserved ejection fraction and recent data show that outcomes in these patients are as bad as in those with reduced ejection fraction. In clinical routine the diagnosis of HFpEF is complicated by indirect assessment of diastolic function. Mechanistically the diastolic dysfunction is among others believed to be caused by the development of diffuse myocardial fibrosis with an increase of extracellular matrix. Direct assessment of the intrinsic diastolic function and stiffness of the ventricle can be obtained by pressure-volume-curve tracings through a conductance catheter. Although this offers the benefit of assessing load-dependent and load-independent parameters of diastolic function as well as information on contractility and ventricular-arterial coupling, the use of this technique is limited by its invasiveness in daily care. Newer MRI techniques have made it possible to quantify not only local fibrosis but also diffuse fibrosis (i.e. T1-Mapping) and determine extracellular volumes. Moreover, the role of right ventricular function is in HFpEF is not well defined. Aim of the current study is therefore to evaluate the role of MRI in assessing cardiac fibrosis in the context of impaired LV diastolic function in HFpEF patients, as well as to evaluate the role of systolic and diastolic right ventricular functional impairment in this patient cohort.

Official Title
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Comparison of Non-invasive Assessment of Cardiac Fibrosis by MRI Derived T1-Mapping and Ventricular Intrinsic Diastolic Function by Pressure-volume-analysis in Patients With Heart Failure With Preserved Ejection Fraction

Conditions
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Heart Failure With Normal Ejection Fraction

Intervention / Treatment
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* Other: Diagnostic P-V-loops and MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LV-EF > 50% Indication for invasive cardiac catheterization Exclusion Criteria: know CAD or CAD in Angiography (stenoses > 50%) acute coronary syndromes Cerebral ischemia within the last year contraindications for MRI more than mild valvular disease Constrictive pericarditis, restrictive Cardiomyopathy, pericardial effusion pregnancy enrolment in other study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HFpEF and servere diastolic dysfuntion<br>Left ventricular ejection fraction (LV-EF) > 50%, echocardiographic criteria for diastolic dysfunction, New York Heart Association classification (NYHA)=>2, Diagnostic P-V-loops and MRI | Other: Diagnostic P-V-loops and MRI<br>* Invasive assessment of P-V-loops during catheterization for suspected CAD Magnetic resonance Imaging for assessment of myocardial fibrosis and biventricular function<br>|
| HFpEF no servere diastolic dysfuntion<br>LV-EF > 50%, no echocardiographic criteria for diastolic dysfunction, NYHA=>2, Diagnostic P-V-loops and MRI | Other: Diagnostic P-V-loops and MRI<br>* Invasive assessment of P-V-loops during catheterization for suspected CAD Magnetic resonance Imaging for assessment of myocardial fibrosis and biventricular function<br>|
| No HF or diastolic dysfunction<br>LV-EF > 50%, no diastolic dysfunction, no heart failure, Diagnostic P-V-loops and MRI | Other: Diagnostic P-V-loops and MRI<br>* Invasive assessment of P-V-loops during catheterization for suspected CAD Magnetic resonance Imaging for assessment of myocardial fibrosis and biventricular function<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of extracellular volume (MRI) and myocardial stiffness (p-v-loops) |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV stiffness constant (ß) between groups |  | Baseline | 
| Time constant of LV-relaxation (Ƭ) between groups |  | Baseline | 
| Change in endiastolic pressure volume relation (EDPVR) under excercise between groups |  | Baseline | 
| Right Ventricular Endsystolic Elastance Slope |  | Baseline | 
| Right Ventricular Endsystolic Stiffness Constant |  | Baseline |