Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT05580068
Eligibility Criteria:
Inclusion Criteria:
* ≥ 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
Exclusion Criteria:
* Lack of capacity to consent
* \< 18 years of age
* No use of a smartphone
* Lack of the physical and mental abilities necessary to use the iATROS app, or generally to use so-called "apps" on a smartphone or tablet.
* Tumor disease associated with a reduced life expectancy of less than 1 year
* Immunosuppression
* Advanced dementia
* Any other disease associated with a reduced life expectancy of less than 1 year
* Any disease/condition that limits participation in the program
* Pregnant or breastfeeding patients
* A secondary hypertension known to the patient (by history)
* Blood pressure at inclusion is \>170mmHg systolic on 24h blood pressure measurement (24h mean) or, alternatively, the at-home blood pressure measurement is \>175mmHg systolic (mean value of the 7 days). In case of a 24h blood pressure measurement, this value is decisive compared to the at-home measurement.
* Existing participation and enrollment in the iATROS hypertension health program.
* Participation in another clinical trial, if complications with compliance, the measures to be performed, a distortion of the results, or the status of a treatment according to the current standard of care result from the participation.
* Comorbidities or the presence of any other physical condition that would prohibit the use of the ESC Hypertension Guideline of 2018 as target blood pressure (i.e. if, due to the patient's individual situation, a different value should be given as a target value for a blood pressure value to be classified as healthy).
* Addictions
* Stroke in the last 3 months
* Transient ischemic attack (TIA) in the last 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05580068
Study Brief:
Protocol Section:
NCT05580068