NCT03671122

PREFERS (Preserved and Reduced Ejection Fraction Epidemiological Regional Study) Stockholm Heart Failure Study

PREFERS PREFERS (Preserved and Reduced Ejection Fraction Epidemiological Regional Study) Stockholm Heart Failure Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 683 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Heart failure (HF) with preserved (HFpEF) or reduced (HFrEF) ejection fraction is associated with poor prognosis and quality of life. While the incidence of HFrEF is declining and HF treatment is effective, HFpEF is increasing, with no established therapy. PREFERS Stockholm is an epidemiological study with the aim of improving clinical care and research in HF and to find new targets for drug treatment in HFpEF starting with a cardiac biopsy study in elective CABG patiens.

Detailed description

Patients with new-onset HF (n = 2000) will be characterized at baseline and after 1-year follow-up by standardized protocols for clinical evaluation, echocardiography, and ECG. In one subset undergoing elective coronary bypass surgery (n = 100) and classified according to LV function, myocardial biopsies will be collected during surgery, and cardiac magnetic resonance (CMR) imaging will be performed at baseline and after 1 year. Blood and tissue samples will be stored in a biobank.We will characterize and compare new-onset HFpEF and HFrEF patients regarding clinical findings and cardiac imaging, genomics, proteomics, and transcriptomics from blood and cardiac biopsies, and by established biomarkers of fibrosis, inflammation, haemodynamics, haemostasis, and thrombosis. The data will be explored by state-of-the-art bioinformatics methods to investigate gene expression patterns, sequence variation, DNA methylation, and post-translational modifications, and using systems biology approaches including pathway and network analysis.In this epidemiological HF study with biopsy studies in a subset of patients, we aim to identify new biomarkers of disease progression and to find pathophysiological mechanisms to support explorations of new treatment regimens for HFpEF.

Conditions

• Heart Failure, Diastolic
• Heart Failure，Congestive

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cardiac imaging in the PREFERS and CABG PREFERS cohorts	performed at baseline and after 1 year
OTHER	Biomarker analysis in the PREFERS and CABG PREFERS chorts	blood samples will be taken for biomarker analysis at baseline and after 1 year
PROCEDURE	Cardiac biopsies in the CABG PREFERS cohort	myocardial biopsies from the right trium the left and right ventricles will be taken during elective CABG

Timeline

• Start date: 2015-01-01
• Primary completion: 2021-01-31
• Completion: 2021-02-28
• First posted: 2018-09-14
• Last updated: 2022-03-31

Locations

1 site across 1 country: Sweden