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Clinical Study for the Investigation and Validation of a Therapy Procedure for the Adjustment of Risk Factors in Patients With Coronary Heart Disease by Means of Digital Therapy Control

NCT06091774 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-03-06

No results posted yet for this study

Summary

This study will test a controlled investigation of the efficacy and effectiveness of iATROS digital therapy management for risk factor adjustment in patients with coronary heart disease (CHD).

Conditions

Interventions

DEVICE

CHD therapy through iATROS medical device

The intervention to be carried out in the treatment group is the use of the therapy control for the treatment of CHD played out via the iATROS medicine product. Patients will receive a suitable and medical device certified measuring device for recording vital parameters. The iATROS app is downloaded to the patient's smartphone and the app is activated by entering a code that identifies the user as a participant in the study. When using the app for the first time, the patient is guided through the first steps of using the app and asked to transfer his or her health data to the app. The therapy control by means of the medication product takes place over the entire duration of the study.

Sponsors & Collaborators

  • iATROS GmbH

    lead INDUSTRY

Principal Investigators

  • Moritz Sinner, PD Dr. med · Medizinische Klinik I und Poliklinik LMU Klinikum Campus Großhadern

  • Stefan Kääb, Prof.Dr.med. · Medizinische Klinik I und Poliklinik LMU Klinikum Campus Großhadern

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-05
Primary Completion
2025-04-30
Completion
2026-10-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06091774 on ClinicalTrials.gov