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

Heart Failure With Preserved Ejection Fraction Clinical Trial

— HOPP-BERN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04395846
• Other study ID #: HOPP-BERN ( 4236 )
• Secondary ID: 2019-02018
• Status: Recruiting
• Start date: March 2, 2020
• Est. completion date: December 31, 2029

Study information

• Verified date: March 2023
• Source: University Hospital Inselspital, Berne
• Contact: Christoph Gräni, PD Dr. PhD
• Phone: 316324508
• Email: christoph.graeni[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Locations

Country	Name	City	State
Switzerland	Inselspital, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major adverse cardiovascular events (MACE)	Composite outcome = the first occurrence of hospitalization for heart failure or all-cause mortality.	Within 5 years
Secondary	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.	Within 5 years

External Links

•   Declaration of Helsinki
•   Human Research Act (HRA)
•   Ordinance on Human Research with the Exception of Clinical trials (HRO)
•   P429 Combining systolic and diastolic feature tracking myocardial strain parameters for a more comprehensive assessment of the different characteristics in HFpEF
•   STROBE statement