Prospective, randomized, controlled, multi-centre study on secondary prevention of chronic ischemic heart disease through a digital program

Prospective, randomized, controlled, multi-centre study on secondary prevention of chronic ischemic heart disease through a digital program - CHANGE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00028081

Enrollment

210

Registered

2022-06-14

Start date

2022-07-29

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

I25

Interventions

Group 1: Treatment Group: uses the App Vantis | KHK und Herzinfarkt (VT*), consisting of the App VantisTherapy and a connectable blood pressure monitor Group 2: Control Group: no intervention

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: (i) Patients aged 18 years and older with chronic ischemic heart disease (I25 according to ICD-10) (ii) Patient understands patient information and agrees to participate in the study in writing

Exclusion criteria

Exclusion criteria: (i) No compatible smartphone available or unable to operate it; (ii) Insufficient understanding of the languages offered in VT (currently only German) (iii) Start of participation in another clinical study after inclusion in the present study (iv) Participation in an ischemic heart disease related rehabilitation measure is planned or less than 2 months ago (v) Dependency or employment relationship to the sponsor or investigator

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the change in systolic blood pressure between V0 and V1 for patients with a systolic blood pressure >139 mmHg at inclusion (V0).	—

Secondary

Measure	Time frame
Secondary endpoints are ? Proportion of patients in the personal target range at V1 (i.e. =65 years old) for patients with a systolic blood pressure >139 mmHg at inclusion (V0) ? Change in systolic blood pressure between V0 and V1 for patients with a systolic blood pressure >129 mmHg at inclusion (V0) ? Change in diastolic blood pressure between V0 and V1 for patients with diastolic blood pressure >89 mmHg at inclusion (V0) ? Proportion of patients that measured and documented blood pressure regularly un at least 8 of the last 14 days priot to V1 (if indicated) for patients with a systolic blood pressure >139 mmHg at inclusion (V0).	—

Measure

Time frame

Secondary endpoints are ? Proportion of patients in the personal target range at V1 (i.e. =65 years old) for patients with a systolic blood pressure >139 mmHg at inclusion (V0) ? Change in systolic blood pressure between V0 and V1 for patients with a systolic blood pressure >129 mmHg at inclusion (V0) ? Change in diastolic blood pressure between V0 and V1 for patients with diastolic blood pressure >89 mmHg at inclusion (V0) ? Proportion of patients that measured and documented blood pressure regularly un at least 8 of the last 14 days priot to V1 (if indicated) for patients with a systolic blood pressure >139 mmHg at inclusion (V0).

—

Countries

Germany

Contacts

Public ContactAndreas Zietzer

Medizinische Klinik und Poliklinik IIInnere Medizin - Kardiologie, Pneumologie und AngiologieUniversitätsklinikum Bonn

andreas.zietzer@ukbonn.de+49 (0) 228 287-51485

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 10, 2026