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

Not Applicable

Active, not recruiting

• Conditions: Heart Failure with Preserved Ejection Fraction
• Interventions: Behavioral: Prevention offer

• Registration Number: NCT05122793
• Lead Sponsor: German Heart Institute

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.

Study Timeline

• Study Start: 2021-06-21
• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-11-04
• Study First Posted: 2021-11-17
• Primary Completion: 2023-04-05
• Status Verified: 2024-10
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Study Completion: 2034-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4509

Inclusion Criteria

• Smoking
• Hypercholesterolaemia
• Arterial hypertension
• Obesity
• Chronic diabetes mellitus
• Chronic kidney disease
• Health insurance

Exclusion Criteria

• Previously diagnosed Heart Failure
• MRI-exclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prevention Group	Prevention offer	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).

Primary Outcome Measures

Name	Time	Method
Improved GLS	12 months	Improved GLS at after one year compared to baseline.

Secondary Outcome Measures

Name	Time	Method
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.
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.
laboratory parameter: HbA1c	12 months	laboratory parameter in mmol/mol 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.

Trial Locations

Locations (1)

Deutsches Herzzentrum der Charité; 🇩🇪 Berlin, Germany