Heart Failure and Preserved Ejection Fraction: Observation of Its Progression and Prognosis (HOPP-BERN)

NCT ID: NCT04395846

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2029-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Known Heart Failure with Preserved Ejection Fraction (HFpEF) (based on invasive measurement) or high probability of HFpEF (>70% based on H2FPEF score ≥4)
• Ability to provide informed consent (knowledge of project languages), >18 years

Exclusion Criteria

• MRI incompatibility (ie. pacemakers, ICD, internal defibrillators)
• Acute myocardial infarction (<90 days)
• Recent cardiovascular surgery or intervention (<90 days)
• Severe valve disease
• Known infiltrative diseases (i.e. amyloidosis, sarcoidosis)
• Known hypertrophic cardiomyopathy)
• ARVC (arrhythmogenic right ventricular cardiomyopathy), non-compaction cardiomyopathy
• Heart transplant
• Treatment for chemotherapy or radiotherapy
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Gräni, PD Dr. PhD

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, Inselspital, Universitätsklinik für Kardiologie

Kady Fischer, PhD

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, Inselspital, Dept. Anaesthesiology and Pain Medicine

Locations

Inselspital, Bern University Hospital

Bern, , Switzerland

Countries

Switzerland

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Related Links

https://www.admin.ch/opc/en/classified-compilation/20121177/index.html

Ordinance on Human Research with the Exception of Clinical trials (HRO)

http://www.admin.ch/opc/en/classified-compilation/20121176/201401010000/810.305.pdf

Human Research Act (HRA)

https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects

Declaration of Helsinki

http://www.jclinepi.com/article/S0895-4356(07)00436-2/pdf

STROBE statement

https://esc365.escardio.org/Congress/EuroCMR-2019/Poster-session-2/191780-combining-systolic-and-diastolic-feature-tracking-myocardial-strain-parameters-for-a-more-comprehensive-assessment-of-the-different-characteristics-in-hfpef

P429 Combining systolic and diastolic feature tracking myocardial strain parameters for a more comprehensive assessment of the different characteristics in HFpEF

Other Identifiers

2019-02018

Identifier Type: OTHER

Identifier Source: secondary_id

HOPP-BERN ( 4236 )

Identifier Type: -

Identifier Source: org_study_id