Rationale and design of the prospective in-hospital detection of elevated blood pressure study (indebp)

Objective: There is a large gap in evidence on how to handle asymptomatically elevated blood pressure (BP) values during non-cardiac hospitalization. Recent data suggests that initiation or up-titration of antihypertensive drugs during hospitalization poses a risk of adverse events, possibly due to over-diagnosis and treatment. The aim of the study is to elucidate the prevalence of new persistent or uncontrolled arterial hypertension (AHT) four weeks after hospital discharge in patients with elevated BP values during hospitalization and to demonstrate safety of postponement of treatment. Design and method: This is a single-center, open-label, prospective, two-phase observation-intervention study. Patients with asymptomatically elevated BP values during non-cardiac hospitalization will be included. The study contains two subsequent periods. In a first control phase, adjustment of BP treatment will be at the discretion of the treating physician without any interference by the study physicians. In the second intervention phase, the patients’ pre-hospital antihypertensive treatment will not be changed during hospitalization. Only bail out medications for safety reasons will be permitted. Four weeks after hospital discharge, all patients will receive a 24h BP measurement (ABPM) (Figure). Patients with new or uncontrolled AHT on ABPM will be offered treatment recommendations according to current guidelines. We plan to enroll 400 participants in each phase. The primary endpoint will be the proportion of new persistant or uncontrolled AHT according to mean ABPM. Furthermore, prevalence of adverse events consisting of intracerebral bleeding, ischemic stroke, myocardial infarction, cardiovascular death or cardiovascular re-hospitalization, falls, acute kidney injury, or electrolyte disturbances will be analyzed. Results: Study received Ethical Committee approval by October 2023 with the first-patient-in November 16th 2023. During the first week we screened 21 patients with enrolment of 6. Main reason not to participate is the lack of consent to attend the ABPM installation due to their poor health. Conclusions: This is the protocol of a new study assessing the outcome of postponement of antihypertensive treatment in patients and adding new insights into the management of asymptomatic BP elevations during non-cardiac hospitalizations.