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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

683 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2021-02-28

Brief Summary

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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.

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Detailed Description

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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

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Heart Failure, Diastolic Heart Failure，Congestive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PREFERS main study

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

Cardiac imaging in the PREFERS and CABG PREFERS cohorts

Intervention Type DIAGNOSTIC_TEST

performed at baseline and after 1 year

Biomarker analysis in the PREFERS and CABG PREFERS chorts

Intervention Type OTHER

blood samples will be taken for biomarker analysis at baseline and after 1 year

CABG PREFERS

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

Cardiac imaging in the PREFERS and CABG PREFERS cohorts

Intervention Type DIAGNOSTIC_TEST

performed at baseline and after 1 year

Biomarker analysis in the PREFERS and CABG PREFERS chorts

Intervention Type OTHER

blood samples will be taken for biomarker analysis at baseline and after 1 year

Cardiac biopsies in the CABG PREFERS cohort

Intervention Type PROCEDURE

myocardial biopsies from the right trium the left and right ventricles will be taken during elective CABG

Interventions

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Cardiac imaging in the PREFERS and CABG PREFERS cohorts

performed at baseline and after 1 year

Intervention Type DIAGNOSTIC_TEST

Biomarker analysis in the PREFERS and CABG PREFERS chorts

blood samples will be taken for biomarker analysis at baseline and after 1 year

Intervention Type OTHER

Cardiac biopsies in the CABG PREFERS cohort

myocardial biopsies from the right trium the left and right ventricles will be taken during elective CABG

Intervention Type PROCEDURE

Other Intervention Names

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Doppler echocardiography and cMRI blood samples

Eligibility Criteria

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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

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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No