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

NCT04395846 | Active Not Recruiting

• 2 other identifiers: HOPP-BERN ( 4236 )2019-02018
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

CMR; HFpEF; Extracellular Volume; Myocardial Oxygenation; Feature Tracking CMR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of adverse clinical events

  Within 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients with heart failure and preserved ejection fraction (HFpEF) that agree to participate in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (26)

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Related Links

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

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: May 20, 2020
• Study Start: March 2, 2020
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

CH (1)