Clinical trial NCT06132451: In-Hospital Detection of Elevated Blood Pressure
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Blood Pressure, High
Keywords: arterial hypertension
elevated blood pressure
ambulatory blood pressure measurement
antihypertensive medication
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Prevalence of persisting new or uncontrolled arterial hypertension
timeFrame: 4 weeks after hospital discharge
measure: Prevalence of a combined hypertensive complication endpoint
timeFrame: Until 4 weeks after hospital discharge
measure: Prevalence of a combined hypotensive complication endpoint
timeFrame: Until 4 weeks after hospital discharge
Secondary outcomes:
measure: Clinic blood pressure measurement in mmHg
timeFrame: At baseline
measure: Research blood pressure measurement in mmHg
timeFrame: At baseline
measure: Prevalence of previously unknown arterial hypertension
timeFrame: At baseline
measure: Prevalence of female gender
timeFrame: At baseline
measure: Prevalence of re-hospitalization for any cause
timeFrame: Until 4 weeks after hospital discharge
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
References: