Heart Failure With Normal Ejection FractionSTIFFMAPNCT02459626
Left Ventricular Stiffness vs. Fibrosis Quantification by T1 Mapping in Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure With Normal Ejection Fraction, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Normal Ejection Fraction
- What is being tested?
- Diagnostic P-V-loops and MRI
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- LV-EF > 50%
- Indication for invasive cardiac catheterization
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Being tested
- Diagnostic P-V-loops and MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Diagnostic P-V-loops and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of extracellular volume (MRI) and myocardial stiffness (p-v-loops)
Measured: Baseline
Secondary outcomes (5)
LV stiffness constant (ß) between groups
Measured: Baseline
Time constant of LV-relaxation (Ƭ) between groups
Measured: Baseline
Change in endiastolic pressure volume relation (EDPVR) under excercise between groups
Measured: Baseline
Right Ventricular Endsystolic Elastance Slope
Measured: Baseline
Right Ventricular Endsystolic Stiffness Constant
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startSep 2014
- Primary completionMay 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Normal Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Center Leipzig - University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Lurz, Heart Center Leipzig - University Hospital
- Investigators
- Philipp Lurz, PhD, Principal investigator, University Heart Center Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459626
- Sponsor's protocol ID
- 1.02
- Acronym
- STIFFMAP
- Status last verified
- May 2021
- First submitted
- 19 May 2015
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16855265Bhatia 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.
PubMed 16855266Burkhoff 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.
PubMed 4006150Westermann 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.
PubMed 18413502Sibley 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.
PubMed 23091172von 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.
PubMed 31053957Rommel 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.
PubMed 29449367von 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.
PubMed 28360259Rommel 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.
PubMed 27081022
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02459626
- Acronym / sponsor ID
- STIFFMAP / 1.02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Heart Center Leipzig - University HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFpEF and servere diastolic dysfuntion | – | Other: Diagnostic P-V-loops and MRILeft ventricular ejection fraction (LV-EF) > 50%, echocardiographic criteria for diastolic dysfunction, New York Heart Association classification (NYHA)=>2, Diagnostic P-V-loops and MRI |
| HFpEF no servere diastolic dysfuntion | – | Other: Diagnostic P-V-loops and MRILV-EF > 50%, no echocardiographic criteria for diastolic dysfunction, NYHA=>2, Diagnostic P-V-loops and MRI |
| No HF or diastolic dysfunction | – | Other: Diagnostic P-V-loops and MRILV-EF > 50%, no diastolic dysfunction, no heart failure, Diagnostic P-V-loops and MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- LV-EF > 50%
- Indication for invasive cardiac catheterization
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic P-V-loops and MRIInvasive assessment of P-V-loops during catheterization for suspected CAD Magnetic resonance Imaging for assessment of myocardial fibrosis and biventricular function | Other | HFpEF and servere diastolic dysfuntion, HFpEF no servere diastolic dysfuntion, No HF or diastolic dysfunction |
Primary outcome
Correlation of extracellular volume (MRI) and myocardial stiffness (p-v-loops)
Time frame: Baseline
5 secondary outcomes
LV stiffness constant (ß) between groups
Time frame: Baseline
Time constant of LV-relaxation (Ƭ) between groups
Time frame: Baseline
Change in endiastolic pressure volume relation (EDPVR) under excercise between groups
Time frame: Baseline
Right Ventricular Endsystolic Elastance Slope
Time frame: Baseline
Right Ventricular Endsystolic Stiffness Constant
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Background: PubMed 16855265Owan 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.
- Background: PubMed 16855266Bhatia 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.
- Background: PubMed 4006150Burkhoff 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.
- Background: PubMed 18413502Westermann 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.
- Background: PubMed 23091172Sibley 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.
- Derived from this study: PubMed 31053957von 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.
- Derived from this study: PubMed 29449367Rommel 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.
- Derived from this study: PubMed 28360259von 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.
- Derived from this study: PubMed 27081022Rommel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Lurz, PhD principal investigator
University Heart Center Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Normal Ejection Fraction, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of extracellular volume (MRI) and myocardial stiffness (p-v-loops) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02459626, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.