Heart Failure with Preserved Ejection Fraction
Conditions
Keywords
Prevention, Heart failure, HFpEF, Asymptomatic, Cardiology, Rural Region, Germany, CMR, Cardiac Magnetic Resonance, HFrEF, Diastolic Dysfunction, Strain, Telemedicine
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPrevention offer
Improvement of outcomes through lifestyle changes and improved health literacy
Sponsors
medneo GmbH, Germany
Medical Statistics, University Medicine of Goettingen
University of Cologne
University Hospital Heidelberg
AOK Nordost
Herz- und Gefaesszentrum Bad Bevensen
German Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
The attending physician who examines the patients is blinded.
Intervention model description
The present study is a prospective, monocentric, randomised controlled trial with stratification and blinded assessment of the endpoint (Prospective Randomised Open Blinded Endpoint (PROBE) design).
Eligibility
Sex/Gender
ALL
Age
40 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Smoking * Hypercholesterolaemia * Arterial hypertension * Obesity * Chronic diabetes mellitus * Chronic kidney disease * Health insurance
Exclusion criteria
* Previously diagnosed Heart Failure * MRI-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improved GLS | 12 months | Improved GLS at after one year compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic and diastolic blood pressure in mmHg | 12 months | blood pressure at baseline compared to after one year. |
| Heart rate in BPM | 12 months | heart rate at baseline compared to after one year. |
| Quality of life questionnaire 1 in Likert scale | 12 months | Quality of life at after one year compared to baseline. Min. value: 0, max value: 3; higher score: better outcome. |
| Quality of life questionnaire 2 in Likert scale | 12 months | Quality of life at after one year compared to baseline. Min. value: 1, max value: 5; higher score: depending on question. |
| laboratory parameters: Iron, transferrin and creatinine | 12 months | laboratory parameters in µmol/l at baseline compared to after one year. |
| laboratory parameters: Sodium, potassium, chloride, total cholesterol, triglycerides, HDL cholesterole, LDL cholesterole, hemoglobin and MCHC | 12 months | laboratory parameters in mmol/l at baseline compared to after one year. |
| laboratory parameters: White cells and platelets | 12 months | laboratory parameters in GPt/l at baseline compared to after one year. |
| laboratory parameters: MCV | 12 months | laboratory parameter in fl at baseline compared to after one year. |
| laboratory parameters: RDW-SD | 12 months | laboratory parameter in fl at baseline compared to after one year. |
| Body weight in kilograms and body height in meters will be aggregated to report BMI in kg/m^2 | 12 months | BMI at baseline compared to after one year. |
| laboratory parameter: red cells | 12 months | laboratory parameter in TPt/l at baseline compared to after one year. |
| laboratory parameter: MCH | 12 months | laboratory parameter in fmol at baseline compared to after one year. |
| laboratory parameter: hematocrit | 12 months | laboratory parameter in l/l at baseline compared to after one year. |
| laboratory parameter: NT-proBNP | 12 months | laboratory parameter in pmol/l at baseline compared to after one year. |
| laboratory parameter: transferrin saturation | 12 months | laboratory parameter in % at baseline compared to after one year. |
| laboratory parameter: ferritin | 12 months | laboratory parameter in µg/l at baseline compared to after one year. |
| hospitalisations of cardiac origin, arrhythmias or death | 12 months | Appearance of hospitalisations of cardiac origin, arrhythmias or death |
| Laboratory parameters: urine albumin-creatinine ratio | 12 months | UACR, calculated from albumin and creatinine in urine in mmol/l at baseline compared to after one year. |
| laboratory parameter: HbA1c | 12 months | laboratory parameter in mmol/mol at baseline compared to after one year. |
Countries
Germany
Outcome results
None listed