Pilot-Studie Zur Explorativen Untersuchung Und Validierung Eines Studienvorhabens Zur Digitalen Therapiesteuerung Von Patienten Mit Arterieller Hypertonie im Vergleich Der Behandlung Mit Dem Standard-of-Care - iATROS eXPLORE

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this pilot study is to exploratively test the basic feasibility of a clinical trial for the controlled investigation of the efficacy and effectiveness of iATROS digital therapy management in the treatment of patients with arterial hypertension within the framework of a clinical trial. In addition, the results of the treatment will be used to generate an initial data basis for the effectiveness of treatment with iATROS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• ≥ 18 years of age

• Existing diagnosis of arterial hypertension according to ICD-10 I10.- to I13.-, i.e. presence of the disease is recorded at the time of inclusion in the study.

• Blood pressure at the time of inclusion is ≥130 mmHg systolic (24h mean) at 24h blood pressure measurement or, alternatively, at-home blood pressure measurement at ≥135 mmHg systolic (mean of 7 days). In case of the presence of a 24-h blood pressure measurement, this value is decisive compared to the at-home measurement.

• Possession and use of a smartphone that allows the installation and use of iATROS, whereby use implies that the patient possesses the physical and mental abilities to use and apply the iATROS app

Locations
Other Locations
Germany
Medizinische Klinik und Poliklinik 1, Ludwig-Maximilians-University of Munich
RECRUITING
Munich
Contact Information
Primary
Paul Weyh
paul.weyh@i-atros.com
+49 176 856 23 142
Backup
Georges von Degenfeld, Dr. med.
georges.degenfeld@i-atros.com
+49 89 - 95879243
Time Frame
Start Date: 2022-11-10
Estimated Completion Date: 2024-10
Participants
Target number of participants: 100
Treatments
Experimental: Intervention Group
The intervention to be carried out in the treatment group is the use of the therapy measures for the treatment of arterial hypertension, which is delivered through the iATROS medical device. The therapy by means of the medical device takes place over 90 days.
No_intervention: Control Group
For the duration of the in-life phase, the treatment of the control group will follow the standard-of-care except for the measures necessary for the conduct of the study.
Related Therapeutic Areas
Sponsors
Leads: iATROS GmbH

This content was sourced from clinicaltrials.gov