Prospective, Randomized, Controlled, Multicenter Study on the Treatment of Hypertension and LDL Cholesterol Using a Digital Program for Patients with Coronary Heart Disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033453

Enrollment

150

Registered

2024-01-23

Start date

2024-01-25

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I25

Interventions

Group 1: Intervention: App “Vantis | KHK und Herzinfarkt” and care as usual Group 2: Control: Care as usual

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
Reduction in systolic blood pressure (sBP) after 25 weeks between the intervention and control groups (confirmatory)	—

Secondary

Measure	Time frame
Confirmatory, hierarchically tested: - Percentage reduction in LDL levels after 25 weeks between the intervention and control groups. - Reduction in systolic blood pressure (sBP) after 13 weeks between the intervention and control groups. Further exploratory analyses, each 13 and 25 weeks after enrollment: - Reduction in diastolic blood pressure for patients with a diastolic blood pressure >84 mmHg at enrollment. - Proportion of patients with sBP within the target range. - Change in Body Mass Index for patients with BMI >25. - Percentage reduction in LDL cholesterol after 13 weeks. - Improvement in therapy adherence measured with "SELF-CARE OF HYPERTENSION – Section A" (v2.0). - Number of days with measured and recorded blood pressure in the last 14 days. - Use of the app in the last 14 days.	—

Measure

Time frame

Confirmatory, hierarchically tested: - Percentage reduction in LDL levels after 25 weeks between the intervention and control groups. - Reduction in systolic blood pressure (sBP) after 13 weeks between the intervention and control groups. Further exploratory analyses, each 13 and 25 weeks after enrollment: - Reduction in diastolic blood pressure for patients with a diastolic blood pressure >84 mmHg at enrollment. - Proportion of patients with sBP within the target range. - Change in Body Mass Index for patients with BMI >25. - Percentage reduction in LDL cholesterol after 13 weeks. - Improvement in therapy adherence measured with "SELF-CARE OF HYPERTENSION – Section A" (v2.0). - Number of days with measured and recorded blood pressure in the last 14 days. - Use of the app in the last 14 days.

—

Countries

Germany

Contacts

Public ContactMaximilian Rödel

Vantis GmbH

max@vantis-health.com+49 89 6931 44840

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026