Back to results"HerzCheck" - Detection of Early Heart Failure Using Telemedicine in Structurally Weak Regions
Primary Purpose
Heart Failure With Preserved Ejection Fraction
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Prevention offer
Sponsored by
About this trial
This is an interventional prevention trial for Heart Failure With Preserved Ejection Fraction focused on measuring Prevention, Heart failure, HFpEF, Asymptomatic, Cardiology, Rural Region, Germany, CMR, Cardiac Magnetic Resonance, HFrEF, Diastolic Dysfunction, Strain, Telemedicine
Eligibility Criteria
Inclusion Criteria:
- Smoking
- Hypercholesterolaemia
- Arterial hypertension
- Diabetes
- Kidney Insufficiency
- Health insurance
Exclusion Criteria:
- HFrEF
- MRI-exclusion criteria
Sites / Locations
- German Heart InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Prevention Group
Control Group
Arm 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).
The control group receives the current standard treatment according to the valid guidelines (Standard of Care = SoC).
Outcomes
Primary Outcome Measures
Improved GLS
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
BMI at baseline compared to after one year.
Systolic and diastolic blood pressure in mmHg
blood pressure at baseline compared to after one year.
Heart rate in BPM
heart rate at baseline compared to after one year.
Quality of life questionnaire 1 in Likert scale
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
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
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
laboratory parameters in mmol/l at baseline compared to after one year.
laboratory parameters: White cells and platelets
laboratory parameters in GPt/l at baseline compared to after one year.
laboratory parameters: MCV
laboratory parameter in fl at baseline compared to after one year.
laboratory parameters: RDW-SD
laboratory parameter in fl at baseline compared to after one year.
laboratory parameter: HbA1c
laboratory parameter in mmol/mol at baseline compared to after one year.
laboratory parameter: red cells
laboratory parameter in TPt/l at baseline compared to after one year.
laboratory parameter: MCH
laboratory parameter in fmol at baseline compared to after one year.
laboratory parameter: hematocrit
laboratory parameter in l/l at baseline compared to after one year.
laboratory parameter: NT-proBNP
laboratory parameter in pmol/l at baseline compared to after one year.
laboratory parameter: transferrin saturation
laboratory parameter in % at baseline compared to after one year.
laboratory parameter: ferritin
laboratory parameter in µg/l at baseline compared to after one year.
hospitalisations of cardiac origin, arrhythmias or death
Appearance of hospitalisations of cardiac origin, arrhythmias or death
Full Information
NCT ID
NCT05122793
First Posted
October 21, 2021
Last Updated
September 18, 2023
Sponsor
German Heart Institute
Collaborators
medneo GmbH, Germany, Medical Statistics, University Medicine of Goettingen, University of Cologne, University Hospital Heidelberg, AOK Nordost, Herz- und Gefaesszentrum Bad Bevensen
1. Study Identification
Unique Protocol Identification Number
NCT05122793
Brief Title
"HerzCheck" - Detection of Early Heart Failure Using Telemedicine in Structurally Weak Regions
Official Title
"HerzCheck" - Erkennung Und Prävention Einer frühen Herzinsuffizienz Mittels Telemedizinischer Verfahren in Strukturschwachen Regionen
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German Heart Institute
Collaborators
medneo GmbH, Germany, Medical Statistics, University Medicine of Goettingen, University of Cologne, University Hospital Heidelberg, AOK Nordost, Herz- und Gefaesszentrum Bad Bevensen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction
Keywords
Prevention, Heart failure, HFpEF, Asymptomatic, Cardiology, Rural Region, Germany, CMR, Cardiac Magnetic Resonance, HFrEF, Diastolic Dysfunction, Strain, Telemedicine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Investigator
Masking Description
The attending physician who examines the patients is blinded.
Allocation
Randomized
Enrollment
6600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prevention Group
Arm Type
Experimental
Arm 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).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group receives the current standard treatment according to the valid guidelines (Standard of Care = SoC).
Intervention Type
Behavioral
Intervention Name(s)
Prevention offer
Intervention Description
Improvement of outcomes through lifestyle changes and improved health literacy
Primary Outcome Measure Information:
Title
Improved GLS
Description
Improved GLS at after one year compared to baseline.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Body weight in kilograms and body height in meters will be aggregated to report BMI in kg/m^2
Description
BMI at baseline compared to after one year.
Time Frame
12 months
Title
Systolic and diastolic blood pressure in mmHg
Description
blood pressure at baseline compared to after one year.
Time Frame
12 months
Title
Heart rate in BPM
Description
heart rate at baseline compared to after one year.
Time Frame
12 months
Title
Quality of life questionnaire 1 in Likert scale
Description
Quality of life at after one year compared to baseline. Min. value: 0, max value: 3; higher score: better outcome.
Time Frame
12 months
Title
Quality of life questionnaire 2 in Likert scale
Description
Quality of life at after one year compared to baseline. Min. value: 1, max value: 5; higher score: depending on question.
Time Frame
12 months
Title
laboratory parameters: Iron, transferrin and creatinine
Description
laboratory parameters in µmol/l at baseline compared to after one year.
Time Frame
12 months
Title
laboratory parameters: Sodium, potassium, chloride, total cholesterol, triglycerides, HDL cholesterole, LDL cholesterole, hemoglobin and MCHC
Description
laboratory parameters in mmol/l at baseline compared to after one year.
Time Frame
12 months
Title
laboratory parameters: White cells and platelets
Description
laboratory parameters in GPt/l at baseline compared to after one year.
Time Frame
12 months
Title
laboratory parameters: MCV
Description
laboratory parameter in fl at baseline compared to after one year.
Time Frame
12 months
Title
laboratory parameters: RDW-SD
Description
laboratory parameter in fl at baseline compared to after one year.
Time Frame
12 months
Title
laboratory parameter: HbA1c
Description
laboratory parameter in mmol/mol at baseline compared to after one year.
Time Frame
12 months
Title
laboratory parameter: red cells
Description
laboratory parameter in TPt/l at baseline compared to after one year.
Time Frame
12 months
Title
laboratory parameter: MCH
Description
laboratory parameter in fmol at baseline compared to after one year.
Time Frame
12 months
Title
laboratory parameter: hematocrit
Description
laboratory parameter in l/l at baseline compared to after one year.
Time Frame
12 months
Title
laboratory parameter: NT-proBNP
Description
laboratory parameter in pmol/l at baseline compared to after one year.
Time Frame
12 months
Title
laboratory parameter: transferrin saturation
Description
laboratory parameter in % at baseline compared to after one year.
Time Frame
12 months
Title
laboratory parameter: ferritin
Description
laboratory parameter in µg/l at baseline compared to after one year.
Time Frame
12 months
Title
hospitalisations of cardiac origin, arrhythmias or death
Description
Appearance of hospitalisations of cardiac origin, arrhythmias or death
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Smoking
Hypercholesterolaemia
Arterial hypertension
Diabetes
Kidney Insufficiency
Health insurance
Exclusion Criteria:
HFrEF
MRI-exclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Kelle, MD
Phone
0049 30 4593 1182
Email
kelle@dhzb.de
First Name & Middle Initial & Last Name or Official Title & Degree
Gisela Thiede, PhD
Phone
0049 1520 9192843
Email
gthiede@dhzb.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Kelle, MD
Organizational Affiliation
German Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katharina Graffmann-Weschke, MD
Organizational Affiliation
AOK Nordost
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Matthias Issing, PhD
Organizational Affiliation
medneo GmbH
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tim Friede, PhD
Organizational Affiliation
Medical Statistics, University Medicine of Goettingen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stephanie Stock, MD
Organizational Affiliation
University of Cologne
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Norbert Frey, MD
Organizational Affiliation
University Hospital Heidelberg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bjoern Remppis, MD
Organizational Affiliation
Herz- und Gefaesszentrum Bad Bevensen
Official's Role
Study Chair
Facility Information:
Facility Name
German Heart Institute
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Kelle, Prof., MD
Phone
0049 30 45931182
Email
kelle@dhzb.de
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
It is not planned to make IPD available to other researchers.
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Links:
URL
https://www.herzcheck.org/startseite/
Description
Project Website in German language
Learn more about this trial
"HerzCheck" - Detection of Early Heart Failure Using Telemedicine in Structurally Weak Regions
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