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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-02018 | Other Identifier | BASEC ID 2019-02018 |
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Analysis of longitudinal data, cardiovascular magnetic resonance (CMR) imaging and health related data, of patients with heart failure and preserved ejection fraction (HFpEF) over a timeframe of 5 years per patient.
In this study routine clinical data are collected along with additional research parameters measured during CMR. CMR will occur throughout a 5-year follow-up.
Heart Failure with Preserved Ejection Fraction (HFpEF) is becoming increasingly prevalent, yet diagnostics, characterization and prognosis of the disease is still uncertain. Multiple contributing factors have been implicated in the development of HFpEF such as but not limited to myocardial fibrosis, myocardial edema, ventricular remodeling, metabolic dysfunction, coronary microvascular dysfunction, ischemia, systemic effects and associated ventricular-arterial coupling. However, how the longitudinal progression of these factors is associated with HFpEF and whether a causal effect between the pathologic features in HFpEF exist, is not fully understood.
Using cardiovascular magnetic resonance (CMR), multiple cardiac and extracardiac parameters can be investigated in a single non-invasive imaging exam. This will be a single-centre prospective observational longitudinal study with the formation of a database. Patients will undergo a comprehensive CMR exam upon recruitment, 1- and 5-years after enrolment, and also if re-hospitalisation for heart failure occurs. This exam will investigate multiple measures of cardiovascular function, myocardial deformation, edema, fibrosis and oxygenation, 4D haemodynamical assessments, along with measurements of the aorta, liver and spleen. Furthermore, clinical data will be collected for the patients for the creation of a HFpEF database (ie. patient characteristics, Kansas City Cardiomyopathy Questionnaire (KCCQ), HF and risk scores, laboratory biomarkers, diagnostic results). With this study, the investigator will be able to quantify longitudinal changes in CMR features within the HFpEF population, and investigate what features are associated with poor prognosis. The data collected will lead to a greater understanding of HFpEF, and hopefully show which clinical or imaging features can be used to identify, and better risk stratify this heterogenous population.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse cardiovascular events (MACE) | Composite outcome = the first occurrence of hospitalization for heart failure or all-cause mortality. | Within 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse clinical events | Incidence of the total adverse clinical events during the follow up time. Adverse clinical events are defined as the occurrence of: hospitalization for heart failure after the CMR, ICD implantation, sustained ventricular tachycardia, cardiac and non-cardiac death, revascularization therapy, valve repair/replacement, myocardial infarction, stroke, hospitalization for angina. |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible patients with heart failure and preserved ejection fraction (HFpEF) that agree to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Gräni, PD Dr. PhD | Insel Gruppe AG, Inselspital, Universitätsklinik für Kardiologie | Principal Investigator |
| Kady Fischer, PhD | Insel Gruppe AG, Inselspital, Dept. Anaesthesiology and Pain Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital, Bern University Hospital | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31504452 | Background | Pieske B, Tschope C, de Boer RA, Fraser AG, Anker SD, Donal E, Edelmann F, Fu M, Guazzi M, Lam CSP, Lancellotti P, Melenovsky V, Morris DA, Nagel E, Pieske-Kraigher E, Ponikowski P, Solomon SD, Vasan RS, Rutten FH, Voors AA, Ruschitzka F, Paulus WJ, Seferovic P, Filippatos G. How to diagnose heart failure with preserved ejection fraction: the HFA-PEFF diagnostic algorithm: a consensus recommendation from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC). Eur Heart J. 2019 Oct 21;40(40):3297-3317. doi: 10.1093/eurheartj/ehz641. | |
| 27206819 |
| Label | URL |
|---|---|
| Declaration of Helsinki | View source |
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| Within 5 years |
| Background |
| Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available. |
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| 29293969 | Background | Taqueti VR, Solomon SD, Shah AM, Desai AS, Groarke JD, Osborne MT, Hainer J, Bibbo CF, Dorbala S, Blankstein R, Di Carli MF. Coronary microvascular dysfunction and future risk of heart failure with preserved ejection fraction. Eur Heart J. 2018 Mar 7;39(10):840-849. doi: 10.1093/eurheartj/ehx721. |
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| P429 Combining systolic and diastolic feature tracking myocardial strain parameters for a more comprehensive assessment of the different characteristics in HFpEF | View source |