NCT02459626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

1.7 years

First QC Date

May 19, 2015

Last Update Submit

May 6, 2021

Conditions

Heart Failure With Normal Ejection Fraction

Outcome Measures

Primary Outcomes (1)

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

    Baseline

Secondary Outcomes (5)

  • 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

Study Arms (3)

HFpEF and servere diastolic dysfuntion

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

HFpEF no servere diastolic dysfuntion

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

Other: Diagnostic P-V-loops and MRI

No HF or diastolic dysfunction

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

Other: Diagnostic P-V-loops and MRI

Interventions

Diagnostic P-V-loops and MRIOTHER

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

HFpEF and servere diastolic dysfuntionHFpEF no servere diastolic dysfuntionNo HF or diastolic dysfunction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Recruitment of consequtive patients from our general cardiology clinic that present with signs of heart failure or suspected CAD with indication for invasive assessment and fullfill eligibility criteria.

You may qualify if:

  • LV-EF \> 50%
  • Indication for invasive cardiac catheterization

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Center of the University Leipzig

Leipzig, 04289, Germany

Location

Related Publications (9)

  • Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.

    PMID: 16855265BACKGROUND

  • Bhatia RS, Tu JV, Lee DS, Austin PC, Fang J, Haouzi A, Gong Y, Liu PP. Outcome of heart failure with preserved ejection fraction in a population-based study. N Engl J Med. 2006 Jul 20;355(3):260-9. doi: 10.1056/NEJMoa051530.

    PMID: 16855266BACKGROUND

  • Burkhoff D, van der Velde E, Kass D, Baan J, Maughan WL, Sagawa K. Accuracy of volume measurement by conductance catheter in isolated, ejecting canine hearts. Circulation. 1985 Aug;72(2):440-7. doi: 10.1161/01.cir.72.2.440.

    PMID: 4006150BACKGROUND

  • Westermann D, Kasner M, Steendijk P, Spillmann F, Riad A, Weitmann K, Hoffmann W, Poller W, Pauschinger M, Schultheiss HP, Tschope C. Role of left ventricular stiffness in heart failure with normal ejection fraction. Circulation. 2008 Apr 22;117(16):2051-60. doi: 10.1161/CIRCULATIONAHA.107.716886. Epub 2008 Apr 14.

    PMID: 18413502BACKGROUND

  • Sibley CT, Noureldin RA, Gai N, Nacif MS, Liu S, Turkbey EB, Mudd JO, van der Geest RJ, Lima JA, Halushka MK, Bluemke DA. T1 Mapping in cardiomyopathy at cardiac MR: comparison with endomyocardial biopsy. Radiology. 2012 Dec;265(3):724-32. doi: 10.1148/radiol.12112721. Epub 2012 Oct 22.

    PMID: 23091172BACKGROUND

  • von Roeder M, Kowallick JT, Rommel KP, Blazek S, Besler C, Fengler K, Lotz J, Hasenfuss G, Lucke C, Gutberlet M, Thiele H, Schuster A, Lurz P. Right atrial-right ventricular coupling in heart failure with preserved ejection fraction. Clin Res Cardiol. 2020 Jan;109(1):54-66. doi: 10.1007/s00392-019-01484-0. Epub 2019 May 3.

    PMID: 31053957DERIVED

  • Rommel KP, von Roeder M, Oberueck C, Latuscynski K, Besler C, Blazek S, Stiermaier T, Fengler K, Adams V, Sandri M, Linke A, Schuler G, Thiele H, Lurz P. Load-Independent Systolic and Diastolic Right Ventricular Function in Heart Failure With Preserved Ejection Fraction as Assessed by Resting and Handgrip Exercise Pressure-Volume Loops. Circ Heart Fail. 2018 Feb;11(2):e004121. doi: 10.1161/CIRCHEARTFAILURE.117.004121.

    PMID: 29449367DERIVED

  • von Roeder M, Rommel KP, Kowallick JT, Blazek S, Besler C, Fengler K, Lotz J, Hasenfuss G, Lucke C, Gutberlet M, Schuler G, Schuster A, Lurz P. Influence of Left Atrial Function on Exercise Capacity and Left Ventricular Function in Patients With Heart Failure and Preserved Ejection Fraction. Circ Cardiovasc Imaging. 2017 Apr;10(4):e005467. doi: 10.1161/CIRCIMAGING.116.005467.

    PMID: 28360259DERIVED

  • Rommel KP, von Roeder M, Latuscynski K, Oberueck C, Blazek S, Fengler K, Besler C, Sandri M, Lucke C, Gutberlet M, Linke A, Schuler G, Lurz P. Extracellular Volume Fraction for Characterization of Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2016 Apr 19;67(15):1815-1825. doi: 10.1016/j.jacc.2016.02.018.

    PMID: 27081022DERIVED

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Philipp Lurz, PhD

    University Heart Center Leipzig

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Investigator, Professor, Managing Senior Physician

Study Record Dates

First Submitted

May 19, 2015

First Posted

June 2, 2015

Study Start

September 1, 2014

Primary Completion

May 1, 2016

Study Completion

December 1, 2018

Last Updated

May 10, 2021

Record last verified: 2021-05

Locations

DE(1)