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

Karolinska Institute

Status: Completed

Conditions: Heart Failure, Diastolic; Heart Failure，Congestive

Treatments: Other: Biomarker analysis in the PREFERS and CABG PREFERS chorts; Procedure: Cardiac biopsies in the CABG PREFERS cohort; Diagnostic Test: Cardiac imaging in the PREFERS and CABG PREFERS cohorts

Study type: Observational

Funder types: Other

Identifiers

NCT03671122

AZ, Molndal, Sweden grant 1377

Details and patient eligibility

About

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.

Full 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.

Enrollment: 683 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:CABG PREFERS

Inclusion criteria:

1. Patients undergoing elective coronary bypass surgery
2. History of heart failure not required
3. Age >18 years
4. Willingness to participate (written informed consent)
5. Possibility to obtain technically satisfactory echocardiography

Inclusion criteria PREFERS:

1. New-onset heart failure according to ESC guidelines including NT-proBNP >125 ng/L at heart failure clinic or >300 ng/L at emergency department visit or hospital admission
2. Age >18 years
3. Willingness to participate (written informed consent)
4. Possibility to obtain technically satisfactory echocardiography

Exclusion Criteria CABG PREFERS and PREFERS:

1. Cognitive impairment
2. Inability to understand Swedish language
3. Anaemia (haemoglobin level <90 g/L)
4. Heart failure primarily due to valvular disease, primary right ventricular failure, pulmonary artery hypertension, hypertrophic obstructive cardiomyopathy Infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis, or haemochromatosis)
5. Severe co-morbidity, severe COPD, severe renal dysfunction (eGFR <30 mL/min/1.73m2). Any other co-morbid disease that will disable the ability to assess or treat heart failure.

Trial design

683 participants in 2 patient groups

PREFERS main study

Description:

500 patients with new onset heart failure will be characterized into those with HFpEFand HFrEF at baseline and undergo Cardiac imaging by Doppler echocardiography and cMRI, blood tests for biomarker analysis

Treatment:

Diagnostic Test: Cardiac imaging in the PREFERS and CABG PREFERS cohorts

Other: Biomarker analysis in the PREFERS and CABG PREFERS chorts

CABG PREFERS

Description:

500 Patients undergoing elective by pass surgery with or without diastolic or systolic dysfunction as Proxy for HFpEF and HFrEF will undergo Cardiac imaging by Doppler echocardiography and cMRI, blood tests for biomarker analysis and cardiac biopsies

Treatment:

Diagnostic Test: Cardiac imaging in the PREFERS and CABG PREFERS cohorts

Procedure: Cardiac biopsies in the CABG PREFERS cohort

Other: Biomarker analysis in the PREFERS and CABG PREFERS chorts