1Universitätsklinikum Bonn Medizinische Klinik und Poliklinik II Bonn, Deutschland; 2Herzzentrum Bonn Medizinische Klinik II Bonn, Deutschland; 3Kardiopraxis Schirmer Kaiserslautern, Deutschland; 4St. Vinzenz-Hospital Innere Medizin III - Kardiologie Köln, Deutschland; 5Krankenhaus der Barmherzigen Brüder Trier Innere Medizin III Trier, Deutschland; 6Krankenhaus Düren Innere Medizin / Kardiologie Düren, Deutschland; 7Kardiologische Gemeinschaftspraxis Leverkusen Leverkusen, Deutschland; 8Praxis Rheingalerie Gemeinschaftspraxis für Innere Medizin und Kardiologie Köln, Deutschland
Background: Coronary artery disease (CAD) is the leading cause of death worldwide. Chronic coronary syndrome (CCS) is an entity of CAD associated with high morbidity and mortality despite therapeutic advances in the last decades. Modifiable risk factors including systolic blood pressure, smoking, diabetes, BMI and Non-HDL cholesterol significantly contribute to cardiovascular death in these patients. Therefore, optimal secondary prevention in patients with CCS includes optimization of systolic blood pressure with lifestyle changes and pharmacological therapy. Current ESC guidelines on hypertension recommend systolic blood pressure to be lower than 140 mmHg in all patients. If the treatment is well tolerated, treated blood pressure values should be targeted to 130/80 mmHg or lower in most patients. The CHANGE study aimed to provide evidence for optimizing secondary prevention in CCS patients using a smartphone app.
Methods: The CHANGE-Study is a prospective, randomized, controlled trial with 1:1 allocation ratio, that was performed in 9 centers in Germany in a parallel group design. The study aimed to investigate the influence of the Vantis | KHK und Herzinfarkt app on blood pressure reduction in CCS patients. Therefore, patients with CCS and high normal blood pressure were randomly allocated to either the control group (standard-of-care) or the intervention group, which was provided with the Vantis | KHK und Herzinfarkt app in addition to standard-of-care. The study was performed in an open design. Outcomes were assessed using objective data from two in-person visits at 0 (baseline) and after 12 weeks. The primary endpoint was reduced systolic blood pressure in patients with a systolic blood pressure >139mmHg at baseline. Secondary endpoints were reduced systolic blood pressure in patients with a systolic blood pressure >129mmHg at baseline, reduced diastolic blood pressure in patients with a diastolic blood pressure >89mmHg at baseline, number of patients with optimal systolic blood pressure and a blood pressure journal.
Results: Among 89 patients, 48.3% had a systolic blood pressure >139 mmHg at baseline, with a mean of 153 mmHg in both the intervention and control group. After 12 weeks, the intervention group showed a significant reduction in systolic blood pressure (15.5 ± 16.7 mmHg, p < 0.001). Patients in the control group showed no significant reduction in systolic blood pressure (6.0 ± 13 mmHg, p=0.058). The difference in blood pressure reduction between both groups was also significant (9.5 ± 15.2 mmHg, p=0.048). This observation was consistent in patients with high normal blood pressure defined as systolic blood pressure >129 mmHg at baseline. Patients using the Vantis | KHK und Herzinfarkt app showed significant systolic blood pressure reduction.
Conclusion: The results of the CHANGE study provide evidence, that a smartphone-guided secondary prevention app compared to standard-of-care has beneficial effects on systolic blood pressure in CCS patients with hypertension and high-normal blood pressure. This adds to the evolving field of interventions in digital cardiology and might lead to improved secondary prevention in CCS patients.