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Heart Failure, DiastolicPREFERSNCT03671122

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

An observational study of Heart Failure, Diastolic and Heart Failure，Congestive, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cardiac imaging in the PREFERS and CABG PREFERS cohorts, Biomarker analysis in the PREFERS and CABG PREFERS chorts and Cardiac biopsies in the CABG PREFERS cohort
Type of treatment
Surgery or procedure
How many people
683 participants
Where
1 siteSweden
Study dates
1 Jan 2015to 28 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: CABG PREFERS: Patients undergoing elective coronary artery by pass surgery at the karolinska University hospital PREFERS: New onset heart failure patients at 5 hospitals in Stockholm ; Danderyds Hospital, Capio St Görans Hospital , Karolinska Solna Karolinska Huddinge, South Hospital

Who may be able to join

  • Patients undergoing elective coronary bypass surgery
  • History of heart failure not required
  • Age >18 years
  • Willingness to participate (written informed consent)
  • Possibility to obtain technically satisfactory echocardiography
  • 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
Show all 9Show fewer
  • Age >18 years
  • Willingness to participate (written informed consent)
  • Possibility to obtain technically satisfactory echocardiography

Who cannot join

  • Cognitive impairment
  • Inability to understand Swedish language
  • Anaemia (haemoglobin level <90 g/L)
  • 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)
  • 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 locations and contacts

1 site in 1 country.

Sweden1 site

  • Karolinska Institutet

    Stockholm, 17176

Other trials in Sweden

About this study

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

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.

Read the 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.

Being tested
Cardiac imaging in the PREFERS and CABG PREFERS cohorts, Biomarker analysis in the PREFERS and CABG PREFERS chorts, Cardiac biopsies in the CABG PREFERS cohort
Medical subject headings
Heart Failure, Diastolic, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac imaging in the PREFERS and CABG PREFERS cohortsDiagnostic test

    Also called Doppler echocardiography and cMRI

    performed at baseline and after 1 year

  • Biomarker analysis in the PREFERS and CABG PREFERS chortsOther

    Also called blood samples

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

  • Cardiac biopsies in the CABG PREFERS cohortProcedure or surgery

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

Study groups in NCT03671122
Study groupRoleWhat they receive
PREFERS main study500 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
Receives: Diagnostic Test: Cardiac imaging in the PREFERS and CABG PREFERS cohorts; Other: Biomarker analysis in the PREFERS and CABG PREFERS chorts
CABG PREFERS500 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
Receives: Diagnostic Test: Cardiac imaging in the PREFERS and CABG PREFERS cohorts; Other: Biomarker analysis in the PREFERS and CABG PREFERS chorts; Procedure: Cardiac biopsies in the CABG PREFERS cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in fibrotic biomarkers

    For the biopsies (CABG PREFERS), the sample size is based upon the number of patients undergoing elective CABG surgery. Investigators expect to discover mRNAs from genes of potential interest in this material with relevance to differences between preserved ejection fraction, reduced ejection fraction and normal groups by bioinformatics tools. These genes will be further investigated in the blood samples of the PREFERS study and potentially in future heart biopsies. for the PREFERS new onset heart failure study. Investigators calculated a 20% difference between HFrEF and HFpEF groups with regard to both PICP and CITP (higher PICP levels and lower CITP in HFpEF vs. HFrEF) as clinically meaningful. To detect a 20% difference between the HFpEF and the HFrEF groups with 80% power and with an estimated drop-out rate of 50 patients in each group, 250 patients in each group are needed to obtain samples from 200 per group.

    Measured: 2 years

  2. Reverse remodeling

    diastolic function

    Measured: 2 years

Secondary outcomes (1)

  1. cardiac magnetic resonance tomography imaging

    ECV by cMRI will be correlated to type of HF whether HFpEF or HFrEF and to echocardiographic findings

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start1 Jan 2015
  3. Primary completion31 Jan 2021
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
683 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03671122
Sponsor's protocol ID
AZ, Molndal, Sweden grant 1377
Acronym
PREFERS
Status last verified
Mar 2022
First submitted
9 Sep 2018
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: none described

Publications

  • Linde C, Eriksson MJ, Hage C, Wallen H, Persson B, Corbascio M, Lundeberg J, Maret E, Ugander M, Persson H; Stockholm County/Karolinska Institutet 4D heart failure investigators. Rationale and design of the PREFERS (Preserved and Reduced Ejection Fraction Epidemiological Regional Study) Stockholm heart failure study: an epidemiological regional study in Stockholm county of 2.1 million inhabitants. Eur J Heart Fail. 2016 Oct;18(10):1287-1297. doi: 10.1002/ejhf.599. Epub 2016 Jul 7.

    PubMed 27384611

  • Asp M, Salmen F, Stahl PL, Vickovic S, Felldin U, Lofling M, Fernandez Navarro J, Maaskola J, Eriksson MJ, Persson B, Corbascio M, Persson H, Linde C, Lundeberg J. Spatial detection of fetal marker genes expressed at low level in adult human heart tissue. Sci Rep. 2017 Oct 11;7(1):12941. doi: 10.1038/s41598-017-13462-5.

    PubMed 29021611

  • Hage C, Lofgren L, Michopoulos F, Nilsson R, Davidsson P, Kumar C, Ekstrom M, Eriksson MJ, Lynga P, Persson B, Wallen H, Gan LM, Persson H, Linde C. Metabolomic Profile in HFpEF vs HFrEF Patients. J Card Fail. 2020 Dec;26(12):1050-1059. doi: 10.1016/j.cardfail.2020.07.010. Epub 2020 Aug 1.

    PubMed 32750486

  • Persson H, Winderud A, Hage C, Cabrera CC, Lofstrom U, Lynga P, Arslan T, Knudsen Malmqvist K, Eriksson MJ, Persson B, Wallen H, Ekstrom M, Linde C. Worse long-term outcomes in new-onset HFpEF vs HFrEF and HFmrEF: findings from the Stockholm PREFERS study. ESC Heart Fail. 2026 May 5;13(3):xvag105. doi: 10.1093/eschf/xvag105.

    PubMed 41967095

  • Lofstrom U, Linde C, Eriksson MJ, Maret E, Corbascio M, Ekstrom M, Lynga P, Wallen H, Persson B, Persson H, Hage C. Baseline characteristics and 1-year outcome by left ventricular function in the CABG PREFERS. Eur Heart J Open. 2025 Mar 5;5(2):oeaf014. doi: 10.1093/ehjopen/oeaf014. eCollection 2025 Mar.

    PubMed 40177505

  • Cabrera C, Frisk C, Lofstrom U, Lynga P, Linde C, Hage C, Persson H, Eriksson MJ, Wallen H, Persson B, Ekstrom M. Relationship between iron deficiency and expression of genes involved in iron metabolism in human myocardium and skeletal muscle. Int J Cardiol. 2023 May 15;379:82-88. doi: 10.1016/j.ijcard.2023.03.032. Epub 2023 Mar 15.

    PubMed 36931398

  • Linde C, Ekstrom M, Eriksson MJ, Maret E, Wallen H, Lynga P, Weden U, Cabrera C, Lofstrom U, Stenudd J, Lund LH, Persson B, Persson H, Hage C; Stockholm County/Karolinska Institutet 4D heart failure investigators. Baseline characteristics of 547 new onset heart failure patients in the PREFERS heart failure study. ESC Heart Fail. 2022 Aug;9(4):2125-2138. doi: 10.1002/ehf2.13922. Epub 2022 Apr 10.

    PubMed 35403374

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, Diastolic and Heart Failure，Congestive, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fibrotic biomarkers (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03671122, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.

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