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

January 5, 2024 updated by: Sebastian Kelle, German Heart Institute

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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, 4,500 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 Type

Interventional

Enrollment (Actual)

4500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sebastian Kelle, MD
  • Phone Number: 0049 30 4593 1182
  • Email: kelle@dhzb.de

Study Contact Backup

  • Name: Gisela Thiede, PhD
  • Phone Number: 0049 1520 9192843
  • Email: gthiede@dhzb.de

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • German Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Smoking
  • Hypercholesterolaemia
  • Arterial hypertension
  • Adiposity
  • Diabetes
  • Kidney Insufficiency
  • Health insurance

Exclusion Criteria:

  • HFrEF
  • MRI-exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved GLS
Time Frame: 12 months
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
Time Frame: 12 months
BMI at baseline compared to after one year.
12 months
Systolic and diastolic blood pressure in mmHg
Time Frame: 12 months
blood pressure at baseline compared to after one year.
12 months
Heart rate in BPM
Time Frame: 12 months
heart rate at baseline compared to after one year.
12 months
Quality of life questionnaire 1 in Likert scale
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
laboratory parameters in mmol/l at baseline compared to after one year.
12 months
laboratory parameters: White cells and platelets
Time Frame: 12 months
laboratory parameters in GPt/l at baseline compared to after one year.
12 months
laboratory parameters: MCV
Time Frame: 12 months
laboratory parameter in fl at baseline compared to after one year.
12 months
laboratory parameters: RDW-SD
Time Frame: 12 months
laboratory parameter in fl at baseline compared to after one year.
12 months
laboratory parameter: HbA1c
Time Frame: 12 months
laboratory parameter in mmol/mol at baseline compared to after one year.
12 months
laboratory parameter: red cells
Time Frame: 12 months
laboratory parameter in TPt/l at baseline compared to after one year.
12 months
laboratory parameter: MCH
Time Frame: 12 months
laboratory parameter in fmol at baseline compared to after one year.
12 months
laboratory parameter: hematocrit
Time Frame: 12 months
laboratory parameter in l/l at baseline compared to after one year.
12 months
laboratory parameter: NT-proBNP
Time Frame: 12 months
laboratory parameter in pmol/l at baseline compared to after one year.
12 months
laboratory parameter: transferrin saturation
Time Frame: 12 months
laboratory parameter in % at baseline compared to after one year.
12 months
laboratory parameter: ferritin
Time Frame: 12 months
laboratory parameter in µg/l at baseline compared to after one year.
12 months
hospitalisations of cardiac origin, arrhythmias or death
Time Frame: 12 months
Appearance of hospitalisations of cardiac origin, arrhythmias or death
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Heart Institute

Collaborators

University of Cologne
University Hospital Heidelberg
medneo GmbH, Germany
Medical Statistics, University Medicine of Goettingen
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2021

Primary Completion (Actual)

April 5, 2023

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

November 4, 2021

First Posted (Actual)

November 17, 2021

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA4/204/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is not planned to make IPD available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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