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Trial record 82 of 900 for:    Recruiting, Not yet recruiting, Available Studies | Congestive heart failure

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

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ClinicalTrials.gov Identifier: NCT03671122
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Cecilia Linde, Karolinska Institutet

Brief 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.

Condition or disease Intervention/treatment
Heart Failure, Diastolic Heart FailureCongestive 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

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PREFERS PREFERS (Preserved and Reduced Ejection Fraction Epidemiological Regional Study) Stockholm Heart Failure Study
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: 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




Primary Outcome Measures :
  1. 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. Reverse remodeling [ Time Frame: 2 years ]
    diastolic function


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
In 500 of the included 1000 patients (CABG-PREFERS) needle biopsies are taken from the cardiac lateral wall of both the right and left ventricle before initiation of cardiac arrest and stored in −70 ∘C for histological and genetic analysis. Moreover biopsies are taken from the right atrial appendage (ample material), the right and left ventricular myocardium, as wellas from the internal mammary artery.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671122


Contacts
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Contact: Camilla Hage, RN PhD 46 8 5177 0000 ext 9282 camilla.hage@ki.se
Contact: Hans E Persson, RN PhD 46 8 1230000 ext 9282 hans.e.persson@sll.se

Locations
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Sweden
Karolinska Institutet Recruiting
Stockholm, Sweden, 17176
Contact: Cecilia M Linde, MD    46 760 52 64 94    cecilia.linde@ki.se   
Contact: Hans E Persson, MD    46-70 48484724    hans.e.persson@sll.se   
Sub-Investigator: Bengt Persson, MD         
Sub-Investigator: Camilla Hage, RN         
Sub-Investigator: Maria J Eriksson, MD         
Sub-Investigator: Håkan Wallen, MD         
Sub-Investigator: Matthias Corbascio, MD         
Sub-Investigator: Mattias Ekström, MD         
Sub-Investigator: Patrik Lyngå, MD         
Sub-Investigator: Martin Ugander, MD         
Sub-Investigator: Eva Maret, MD         
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Cecilia M Linde, MD PhD Institution of Internal medicine, Karolinska University Hospital and Karolinska Institutet

Publications of Results:
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Responsible Party: Cecilia Linde, MD PhD Senior Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03671122     History of Changes
Other Study ID Numbers: AZ, Molndal, Sweden grant 1377
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: none described

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases