HerzCheck - Detection of Early Heart Failure Using Telemedicine in Structurally Weak Regions

Study Overview
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Brief Summary
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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
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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 will be followed by early initiation of appropriate therapeutic measures to improve the prognosis of the affected patients, avoid hospitalisations and save therapy costs, and will be 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, 6,600 patients aged between 40 and 69 years who have characteristic risk factors for the development of heart failure will be examined using a mobile cardiac screening MRI in the federal states of Brandenburg and Mecklenburg-Western Pomerania within Germany.

Official Title
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HerzCheck - Erkennung Und Prävention Einer frühen Herzinsuffizienz Mittels Telemedizinischer Verfahren in Strukturschwachen Regionen

Conditions
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Heart Failure With Preserved Ejection Fraction

Intervention / Treatment
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* Behavioral: Prevention offer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoking Hypercholesterolaemia Arterial hypertension Diabetes Kidney Insufficiency Health insurance Exclusion Criteria: HFrEF MRI-exclusion criteria

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention Group<br>In addition to the usual treatment (SoC), the prevention group receives an innovative prevention offer tailored to the severity of the heart failure (telemedical connection via health app as well as additional therapy recommendations). | Behavioral: Prevention offer<br>* Improvement of outcomes through lifestyle changes and improved health literacy<br>|
| No Intervention: Control Group<br>The control group receives the current standard treatment according to the valid guidelines (Standard of Care = SoC). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved GLS | Improved GLS at after one year compared to baseline. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| Systolic and diastolic blood pressure in mmHg | blood pressure at baseline compared to after one year. | 12 months | 
| Heart rate in BPM | heart rate at baseline compared to after one year. | 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. | 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. | 12 months | 
| laboratory parameters: Iron, transferrin and creatinine | laboratory parameters in µmol/l at baseline compared to after one year. | 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. | 12 months | 
| laboratory parameters: White cells and platelets | laboratory parameters in GPt/l at baseline compared to after one year. | 12 months | 
| laboratory parameters: MCV | laboratory parameter in fl at baseline compared to after one year. | 12 months | 
| laboratory parameters: RDW-SD | laboratory parameter in fl at baseline compared to after one year. | 12 months | 
| laboratory parameter: HbA1c | laboratory parameter in mmol/mol at baseline compared to after one year. | 12 months | 
| laboratory parameter: red cells | laboratory parameter in TPt/l at baseline compared to after one year. | 12 months | 
| laboratory parameter: MCH | laboratory parameter in fmol at baseline compared to after one year. | 12 months | 
| laboratory parameter: hematocrit | laboratory parameter in l/l at baseline compared to after one year. | 12 months | 
| laboratory parameter: NT-proBNP | laboratory parameter in pmol/l at baseline compared to after one year. | 12 months | 
| laboratory parameter: transferrin saturation | laboratory parameter in % at baseline compared to after one year. | 12 months | 
| laboratory parameter: ferritin | laboratory parameter in µg/l at baseline compared to after one year. | 12 months | 
| hospitalisations of cardiac origin, arrhythmias or death | Appearance of hospitalisations of cardiac origin, arrhythmias or death | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Heart failure, HFpEF, Asymptomatic, Cardiology, Rural Region, Germany, CMR, Cardiac Magnetic Resonance, HFrEF, Diastolic Dysfunction, Strain, Telemedicine