Left Ventricular Stiffness vs. Fibrosis Quantification by T1 Mapping in Heart Failure With Preserved Ejection Fraction
- Conditions
- Heart Failure With Normal Ejection Fraction
- Interventions
- Other: Diagnostic P-V-loops and MRI
- Registration Number
- NCT02459626
- Lead Sponsor
- Heart Center Leipzig - University Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- LV-EF > 50%
- Indication for invasive cardiac catheterization
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HFpEF no servere diastolic dysfuntion Diagnostic P-V-loops and MRI LV-EF \> 50%, no echocardiographic criteria for diastolic dysfunction, NYHA=\>2, Diagnostic P-V-loops and MRI HFpEF and servere diastolic dysfuntion Diagnostic P-V-loops and MRI 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 No HF or diastolic dysfunction Diagnostic P-V-loops and MRI LV-EF \> 50%, no diastolic dysfunction, no heart failure, Diagnostic P-V-loops and MRI
- Primary Outcome Measures
Name Time Method Correlation of extracellular volume (MRI) and myocardial stiffness (p-v-loops) Baseline
- Secondary Outcome Measures
Name Time Method Change in endiastolic pressure volume relation (EDPVR) under excercise between groups Baseline LV stiffness constant (ß) between groups Baseline Time constant of LV-relaxation (Ƭ) between groups Baseline Right Ventricular Endsystolic Elastance Slope Baseline Right Ventricular Endsystolic Stiffness Constant Baseline
Trial Locations
- Locations (1)
Heart Center of the University Leipzig
🇩🇪Leipzig, Germany