This study is intended to provide a basis for decision-making for the improved medical care of patients with asymptomatic heart failure, especially in structurally weak regions.
The aim of the study is the early detection of asymptomatic heart failure with a quality-assured cardiac screening MRI in the population in structurally weak regions and especially in patients with risk factors for the occurrence of heart failure. The diagnosis is followed by early initiation of appropriate therapeutic measures to improve the prognosis of the affected patients, avoid hospitalisations and save therapy costs, and is combined with recommended measures to minimise risk factors for the development of heart failure. The project includes a prospective, monocentric, randomised controlled clinical trial with blinded assessment of the endpoint (PROBE design). Within the scope of the study, 4,509 patients aged between 40 and 69 years who have characteristic risk factors for the development of heart failure were examined using a mobile cardiac screening MRI in the federal states of Brandenburg and Mecklenburg-Western Pomerania within Germany.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
4,509
Improvement of outcomes through lifestyle changes and improved health literacy
Deutsches Herzzentrum der Charité
Berlin, State of Berlin, Germany
Improved GLS
Improved GLS at after one year compared to baseline.
Time frame: 12 months
Body weight in kilograms and body height in meters will be aggregated to report BMI in kg/m^2
BMI at baseline compared to after one year.
Time frame: 12 months
Systolic and diastolic blood pressure in mmHg
blood pressure at baseline compared to after one year.
Time frame: 12 months
Heart rate in BPM
heart rate at baseline compared to after one year.
Time frame: 12 months
Quality of life questionnaire 1 in Likert scale
Quality of life at after one year compared to baseline. Min. value: 0, max value: 3; higher score: better outcome.
Time frame: 12 months
Quality of life questionnaire 2 in Likert scale
Quality of life at after one year compared to baseline. Min. value: 1, max value: 5; higher score: depending on question.
Time frame: 12 months
laboratory parameters: Iron, transferrin and creatinine
laboratory parameters in µmol/l at baseline compared to after one year.
Time frame: 12 months
laboratory parameters: Sodium, potassium, chloride, total cholesterol, triglycerides, HDL cholesterole, LDL cholesterole, hemoglobin and MCHC
laboratory parameters in mmol/l at baseline compared to after one year.
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Time frame: 12 months
laboratory parameters: White cells and platelets
laboratory parameters in GPt/l at baseline compared to after one year.
Time frame: 12 months
laboratory parameters: MCV
laboratory parameter in fl at baseline compared to after one year.
Time frame: 12 months
laboratory parameters: RDW-SD
laboratory parameter in fl at baseline compared to after one year.
Time frame: 12 months
laboratory parameter: HbA1c
laboratory parameter in mmol/mol at baseline compared to after one year.
Time frame: 12 months
laboratory parameter: red cells
laboratory parameter in TPt/l at baseline compared to after one year.
Time frame: 12 months
laboratory parameter: MCH
laboratory parameter in fmol at baseline compared to after one year.
Time frame: 12 months
laboratory parameter: hematocrit
laboratory parameter in l/l at baseline compared to after one year.
Time frame: 12 months
laboratory parameter: NT-proBNP
laboratory parameter in pmol/l at baseline compared to after one year.
Time frame: 12 months
laboratory parameter: transferrin saturation
laboratory parameter in % at baseline compared to after one year.
Time frame: 12 months
laboratory parameter: ferritin
laboratory parameter in µg/l at baseline compared to after one year.
Time frame: 12 months
hospitalisations of cardiac origin, arrhythmias or death
Appearance of hospitalisations of cardiac origin, arrhythmias or death
Time frame: 12 months
Laboratory parameters: urine albumin-creatinine ratio
UACR, calculated from albumin and creatinine in urine in mmol/l at baseline compared to after one year.
Time frame: 12 months