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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02459626
Acronym
STIFFMAP
Enrollment
36
Registered
2015-06-02
Start date
2014-09-30
Completion date
2018-12-31
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Normal Ejection Fraction

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.

Interventions

OTHERDiagnostic P-V-loops and MRI

Invasive assessment of P-V-loops during catheterization for suspected CAD Magnetic resonance Imaging for assessment of myocardial fibrosis and biventricular function

Sponsors

Heart Center Leipzig - University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Correlation of extracellular volume (MRI) and myocardial stiffness (p-v-loops)Baseline

Secondary

MeasureTime frame
LV stiffness constant (ß) between groupsBaseline
Time constant of LV-relaxation (Ƭ) between groupsBaseline
Change in endiastolic pressure volume relation (EDPVR) under excercise between groupsBaseline
Right Ventricular Endsystolic Elastance SlopeBaseline
Right Ventricular Endsystolic Stiffness ConstantBaseline

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026