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

March 29, 2022 updated by: Cecilia Linde, Karolinska Institutet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

683

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: Cardiac imaging in the PREFERS and CABG PREFERS cohorts
performed at baseline and after 1 year
Other Names:
  • Doppler echocardiography and cMRI
Other: Biomarker analysis in the PREFERS and CABG PREFERS chorts
blood samples will be taken for biomarker analysis at baseline and after 1 year
Other Names:
  • blood samples
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
Diagnostic test: Cardiac imaging in the PREFERS and CABG PREFERS cohorts
performed at baseline and after 1 year
Other Names:
  • Doppler echocardiography and cMRI
Other: Biomarker analysis in the PREFERS and CABG PREFERS chorts
blood samples will be taken for biomarker analysis at baseline and after 1 year
Other Names:
  • blood samples
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fibrotic biomarkers
Time Frame: 2 years
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.
2 years
Reverse remodeling
Time Frame: 2 years
diastolic function
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac magnetic resonance tomography imaging
Time Frame: 2 years
ECV by cMRI will be correlated to type of HF whether HFpEF or HFrEF and to echocardiographic findings
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

The Swedish Research Council
Region Stockholm

Investigators

  • Principal Investigator: Cecilia M Linde, MD PhD, Institution of Internal medicine, Karolinska University Hospital and Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

January 31, 2021

Study Completion (ACTUAL)

February 28, 2021

Study Registration Dates

First Submitted

September 9, 2018

First Submitted That Met QC Criteria

September 13, 2018

First Posted (ACTUAL)

September 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZ, Molndal, Sweden grant 1377

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

none described

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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