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

German Heart Institute

Status: Active, not recruiting

Conditions: Heart Failure with Preserved Ejection Fraction

Treatments: Behavioral: Prevention offer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05122793

EA4/204/20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,509 patients

Sex: All

Ages: 40 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Previously diagnosed Heart Failure
• MRI-exclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4,509 participants in 2 patient groups

Prevention Group

Experimental group

Description:

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).

Treatment:

Behavioral: Prevention offer

Control Group

No Intervention group

Description:

The control group receives the current standard treatment according to the valid guidelines (Standard of Care = SoC).