Prospective, randomized, controlled,multi-centre study on secondary prevention ofchronic ischemicheart disease through a digital program

Phase 4

• Conditions: I25; Chronic ischaemic heart disease

• Registration Number: DRKS00028081
• Lead Sponsor: Vantis GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-14
• Study Completion: 2023-06-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 180

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

(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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary endpoints are<br>? Proportion of patients in the personal target range at V1 (i.e. <=129 mmHg systolic if <65 years old, <=139 mmHg if >=65 years old) for patients with a systolic blood pressure >139 mmHg at inclusion (V0)<br>? Change in systolic blood pressure between V0 and V1 for patients with a systolic blood pressure >129 mmHg at inclusion (V0)<br>? Change in diastolic blood pressure between V0 and V1 for patients with diastolic blood pressure >89 mmHg at inclusion (V0)<br>? 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).