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

Heart Center Leipzig - University Hospital

Status

Completed

Conditions

Heart Failure With Normal Ejection Fraction

Treatments

Other: Diagnostic P-V-loops and MRI

Study type

Observational

Funder types

Other

Identifiers

NCT02459626

1.02

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

36 participants in 3 patient groups

HFpEF and servere diastolic dysfuntion

Description:

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

Treatment:

Other: Diagnostic P-V-loops and MRI

HFpEF no servere diastolic dysfuntion

Description:

LV-EF \> 50%, no echocardiographic criteria for diastolic dysfunction, NYHA=\>2, Diagnostic P-V-loops and MRI

Treatment:

Other: Diagnostic P-V-loops and MRI

No HF or diastolic dysfunction

Description:

LV-EF \> 50%, no diastolic dysfunction, no heart failure, Diagnostic P-V-loops and MRI

Treatment:

Other: Diagnostic P-V-loops and MRI