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

Sponsor

German Heart Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05122793

Collaborator

medneo GmbH, Germany (Other), Medical Statistics, University Medicine of Goettingen (Other), University of Cologne (Other), University Hospital Heidelberg (Other), AOK Nordost (Other), Herz- und Gefaesszentrum Bad Bevensen (Other)

6,600

Enrollment

Location

Arms

31.3

Anticipated Duration (Months)

210.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure With Preserved Ejection Fraction	Behavioral: Prevention offer	N/A

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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

6600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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 (Investigator)

Masking Description:

The attending physician who examines the patients is blinded.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 21, 2021

Anticipated Primary Completion Date :

May 31, 2023

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prevention Group 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 Improvement of outcomes through lifestyle changes and improved health literacy
No Intervention: Control Group The control group receives the current standard treatment according to the valid guidelines (Standard of Care = SoC).

Arm

Intervention/Treatment

Experimental: Prevention Group

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

Improvement of outcomes through lifestyle changes and improved health literacy

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

Improved GLS [12 months]
Improved GLS at after one year compared to baseline.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Smoking
Hypercholesterolaemia
Arterial hypertension
Diabetes
Kidney Insufficiency
Health insurance

Exclusion Criteria:

HFrEF
MRI-exclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	German Heart Institute	Berlin		Germany	13353

Sponsors and Collaborators

German Heart Institute
medneo GmbH, Germany
Medical Statistics, University Medicine of Goettingen
University of Cologne
University Hospital Heidelberg
AOK Nordost
Herz- und Gefaesszentrum Bad Bevensen

Investigators

Principal Investigator: Sebastian Kelle, MD, German Heart Institute
Study Chair: Katharina Graffmann-Weschke, MD, AOK Nordost
Study Chair: Matthias Issing, PhD, medneo GmbH
Study Chair: Tim Friede, PhD, Medical Statistics, University Medicine of Goettingen
Study Chair: Stephanie Stock, MD, University of Cologne
Study Chair: Norbert Frey, MD, University Hospital Heidelberg
Study Chair: Bjoern Remppis, MD, Herz- und Gefaesszentrum Bad Bevensen