In-Hospital Detection of Elevated Blood Pressure

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to analyse the prevalence of new or uncontrolled arterial hypertension (AHT) after hospital discharge of medical in-patients with elevated blood pressure (BP) values during hospitalisation. The main questions it aims to answer are: Do elevated BP values during hospitalisation correspond to new or uncontrolled AHT after hospital discharge? Is it safe to postpone adaption of antihypertensive treatment until after proper evaluation of AHT after hospital discharge? Participants will either be treated according to their physicians' decision or antihypertensive treatment adaptions will be postponed until after hospital discharge.

Official Title
-----------------
In-Hospital Detection of Elevated Blood Pressure (INDEBP): Prevalence of New or Uncontrolled Hypertension and Safety of Postponement of Antihypertensive Treatment Adaption in Medical In-patients

Conditions
-----------------
Hypertension, Blood Pressure, High

Intervention / Treatment
-----------------
* Other: Postponement of antihypertensive treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient hospitalized on the internal medicine ward for non-cardiovascular causes, i.e. patients hospitalized for conditions, which are not acutely worsened by uncontrolled AHT Asymptomatic elevated BP values (defined as 140-180 mmHg systolic and/or 90-110 mmHg diastolic) on at least 2 occasions Ability to understand study procedures and to provide written informed consent Exclusion Criteria: Hospitalization for any conditions which can be worsened by uncontrolled AHT: Cerebrovascular events Acute coronary syndrome Acute or decompensated heart failure Any condition preventing ABPM Pregnant or lactating women Failure to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be block-wise randomization. During the first block, the study team will not interfere with the treating physician, in order to ensure that they will treat the patient according to what they perceive as the current usual practice. During the second block the patients receive no change of their original antihypertensive treatment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual practice arm<br>Patients will be treated according to their treating physicians' decision. | |
| Other: Postponement of treatment arm<br>Antihypertensive treatment adaptions will be postponed until after a 24h ambulatory blood pressure measurement (ABPM) 4 weeks after hospital discharge. | Other: Postponement of antihypertensive treatment<br>* Hypertensive blood pressure values in medical in-patients will not be treated during hospitalisation until confirmed by ABPM 4 weeks after hospital discharge<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of persisting new or uncontrolled arterial hypertension | Elevated blood pressure values in ambulatory blood pressure monitoring | 4 weeks after hospital discharge | 
| Prevalence of a combined hypertensive complication endpoint | Consisting of intracerebral bleeding, ischemic stroke, myocardial infarction, cardiovascular death or cardiovascular re-hospitalization | Until 4 weeks after hospital discharge | 
| Prevalence of a combined hypotensive complication endpoint | Consisting of falls, acute kidney injury, electrolyte disturbances, re-hospitalizations due to hypotension, or BP values on ABPM below the lower treatment limit | Until 4 weeks after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinic blood pressure measurement in mmHg | Documented in the patient documentation | At baseline | 
| Research blood pressure measurement in mmHg | Standardized blood pressure measurement taken by research staff | At baseline | 
| Prevalence of previously unknown arterial hypertension | No previously documented diagnosis of arterial hypertension and no antihypertensive treatment | At baseline | 
| Prevalence of female gender | As reported by participant | At baseline | 
| Prevalence of re-hospitalization for any cause | According to hospital documentation and patient interrogation | Until 4 weeks after hospital discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arterial hypertension, elevated blood pressure, ambulatory blood pressure measurement, antihypertensive medication