Prospective, Randomized, Controlled, Multicenter Study on the Treatment of Hypertension and LDL Cholesterol Using a Digital Program for Patients with Coronary Heart Disease
- Conditions
- I25Chronic ischaemic heart disease
- Registration Number
- DRKS00033453
- Lead Sponsor
- Vantis GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
patients with chronich ischemic heart disease (I25) and increased blood pressure (min. grade 1 as per ESC guideline, ICD-10: I10-I13)
- patient understands the patient information and gives written consent for study participation
- no compatible smartphone available or lacking knowledge of smartphone usage
- insufficient understanding of the offered language (German)
- start of study participation in another clinical study after inclusion in the present study
- participation in a lifestyle-related rehabilitation, or device-based blood pressure therapy, or such a rehabilitation/therapy has been conducted in the last 2 months
- critical or unstable health status
- dependency or employment relation to the sponsor or investigator
- prior usage of a comparable digital therapy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in systolic blood pressure (sBP) after 25 weeks between the intervention and control groups (confirmatory)
- Secondary Outcome Measures
Name Time Method Confirmatory, hierarchically tested:<br>- Percentage reduction in LDL levels after 25 weeks between the intervention and control groups.<br>- Reduction in systolic blood pressure (sBP) after 13 weeks between the intervention and control groups.<br><br>Further exploratory analyses, each 13 and 25 weeks after enrollment:<br>- Reduction in diastolic blood pressure for patients with a diastolic blood pressure >84 mmHg at enrollment.<br>- Proportion of patients with sBP within the target range.<br>- Change in Body Mass Index for patients with BMI >25.<br>- Percentage reduction in LDL cholesterol after 13 weeks.<br>- Improvement in therapy adherence measured with SELF-CARE OF HYPERTENSION – Section A (v2.0).<br>- Number of days with measured and recorded blood pressure in the last 14 days.<br>- Use of the app in the last 14 days.