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

Sponsor

University Hospital Inselspital, Berne (Other)

Overall Status

Recruiting

CT.gov ID

NCT04395846

Collaborator

(none)

350

Enrollment

Location

118

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure With Preserved Ejection Fraction

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

350 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 2, 2020

Anticipated Primary Completion Date :

Dec 31, 2029

Anticipated Study Completion Date :

Dec 31, 2029

Outcome Measures

Primary Outcome Measures

Incidence of major adverse cardiovascular events (MACE) [Within 5 years]
Composite outcome = the first occurrence of hospitalization for heart failure or all-cause mortality.

Secondary Outcome Measures

Incidence of adverse clinical events [Within 5 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inselspital, Bern University Hospital	Bern		Switzerland	3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

Principal Investigator: 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