Last updated: March 5, 2024
Sponsor: iATROS GmbH
Overall Status: Active - Recruiting
Phase
N/A
Condition
Stress
Circulation Disorders
Williams Syndrome
Treatment
Hypertension therapy through iATROS medical device
Clinical Study ID
NCT05580068
02
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 bloodpressure measurement or, alternatively, at-home blood pressure measurement at ≥135mmHg systolic (mean of 7 days). In case of the presence of a 24-h blood pressuremeasurement, 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 touse and apply the iATROS app
Exclusion
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, orgenerally 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 >175mmHgsystolic (mean value of the 7 days). In case of a 24h blood pressure measurement, thisvalue 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, themeasures to be performed, a distortion of the results, or the status of a treatmentaccording to the current standard of care result from the participation.
- Comorbidities or the presence of any other physical condition that would prohibit theuse of the ESC Hypertension Guideline of 2018 as target blood pressure (i.e. if, dueto the patient's individual situation, a different value should be given as a targetvalue 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
Study Design
Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Hypertension therapy through iATROS medical device
Phase:
Study Start date:
November 10, 2022
Estimated Completion Date:
October 31, 2024
Study Description
Connect with a study center
Medizinische Klinik und Poliklinik 1, Ludwig-Maximilians-University of Munich
Munich, Bavaria 80336
GermanyActive - Recruiting
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