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Completed

NCT Number: NCT02459626

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

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.

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Key information

Conditions

Heart Failure With Normal Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Center of the University Leipzig

Leipzig, 04289, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic P-V-loops and MRI

Other

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

Primary outcomes

  1. Correlation of extracellular volume (MRI) and myocardial stiffness (p-v-loops)

    Time frame: Baseline

Secondary outcomes

  1. LV stiffness constant (ß) between groups

    Time frame: Baseline

  2. Time constant of LV-relaxation (Ƭ) between groups

    Time frame: Baseline

  3. Change in endiastolic pressure volume relation (EDPVR) under excercise between groups

    Time frame: Baseline

  4. Right Ventricular Endsystolic Elastance Slope

    Time frame: Baseline

  5. Right Ventricular Endsystolic Stiffness Constant

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Heart Center Leipzig - University Hospital

Other

Registry information

Official study title

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

Acronym: STIFFMAP

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Jun 2, 2015
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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