"HerzCheck" - Erkennung Und Prävention Einer Frühen Herzinsuffizienz Mittels Telemedizinischer Verfahren in Strukturschwachen Regionen
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- German Heart Institute
- Enrollment
- 4509
- Locations
- 1
- Primary Endpoint
- Improved GLS
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Sebastian Kelle
Dr. Sebastian Kelle (MD)
German Heart Institute
Eligibility Criteria
Inclusion Criteria
- •Hypercholesterolaemia
- •Arterial hypertension
- •Chronic diabetes mellitus
- •Chronic kidney disease
- •Health insurance
Exclusion Criteria
- •Previously diagnosed Heart Failure
- •MRI-exclusion criteria
Outcomes
Primary Outcomes
Improved GLS
Time Frame: 12 months
Improved GLS at after one year compared to baseline.
Secondary Outcomes
- Body weight in kilograms and body height in meters will be aggregated to report BMI in kg/m^2(12 months)
- Systolic and diastolic blood pressure in mmHg(12 months)
- Heart rate in BPM(12 months)
- Quality of life questionnaire 1 in Likert scale(12 months)
- Quality of life questionnaire 2 in Likert scale(12 months)
- laboratory parameters: Iron, transferrin and creatinine(12 months)
- laboratory parameters: Sodium, potassium, chloride, total cholesterol, triglycerides, HDL cholesterole, LDL cholesterole, hemoglobin and MCHC(12 months)
- laboratory parameters: White cells and platelets(12 months)
- laboratory parameters: MCV(12 months)
- laboratory parameters: RDW-SD(12 months)
- laboratory parameter: HbA1c(12 months)
- laboratory parameter: red cells(12 months)
- laboratory parameter: MCH(12 months)
- laboratory parameter: hematocrit(12 months)
- laboratory parameter: NT-proBNP(12 months)
- laboratory parameter: transferrin saturation(12 months)
- laboratory parameter: ferritin(12 months)
- hospitalisations of cardiac origin, arrhythmias or death(12 months)
- Laboratory parameters: urine albumin-creatinine ratio(12 months)