Heart Failure With Normal Ejection Fraction Clinical Trial
— STIFFMAPOfficial 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
NCT number | NCT02459626 |
Other study ID # | 1.02 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2014 |
Est. completion date | December 2018 |
Verified date | May 2021 |
Source | Heart Center Leipzig - University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | December 2018 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Heart Center of the University Leipzig | Leipzig |
Lead Sponsor | Collaborator |
---|---|
Heart Center Leipzig - University Hospital |
Germany,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Westermann D, Kasner M, Steendijk P, Spillmann F, Riad A, Weitmann K, Hoffmann W, Poller W, Pauschinger M, Schultheiss HP, Tschöpe 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of extracellular volume (MRI) and myocardial stiffness (p-v-loops) | Baseline | ||
Secondary | LV stiffness constant (ß) between groups | Baseline | ||
Secondary | Time constant of LV-relaxation (?) between groups | Baseline | ||
Secondary | Change in endiastolic pressure volume relation (EDPVR) under excercise between groups | Baseline | ||
Secondary | Right Ventricular Endsystolic Elastance Slope | Baseline | ||
Secondary | Right Ventricular Endsystolic Stiffness Constant | Baseline |
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