An observational study in Heart Failure With Preserved Ejection Fraction, sponsored by Insel Gruppe AG, University Hospital Bern. Active, not recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 350 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Eligible patients with heart failure and preserved ejection fraction (HFpEF) that agree to participate in the study.
Exclusion Criteria:
Incidence of major adverse cardiovascular events (MACE)
Composite outcome = the first occurrence of hospitalization for heart failure or all-cause mortality.
Time frame: Within 5 years
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.
Time frame: Within 5 years
Plan to share: Undecided
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern