In-Hospital Detection of Elevated Blood Pressure (INDEBP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Blood Pressure, High
• Intervention / Treatment: Other: Postponement of antihypertensive treatment

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual practice arm; Patients will be treated according to their treating physicians' decision.
Other: Postponement of treatment arm; 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; Hypertensive blood pressure values in medical in-patients will not be treated during hospitalisation until confirmed by ABPM 4 weeks after hospital discharge

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

Collaborators and Investigators

• Sponsor: Annina Vischer

Study record dates

Study Major Dates

• Study Start (Estimated): November 7, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 5, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: arterial hypertension; elevated blood pressure; antihypertensive medication; ambulatory blood pressure measurement
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Antihypertensive Agents
• Other Study ID Numbers: INDEBP-prospective; 2023-01566 (Other Identifier: EKNZ)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No