In-Hospital Detection of Elevated Blood Pressure

Hypertension Clinical Trial

— INDEBP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06132451
• Other study ID #: INDEBP-prospective
• Secondary ID: 2023-01566
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 7, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure, High
• Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Annina Vischer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of persisting new or uncontrolled arterial hypertension	Elevated blood pressure values in ambulatory blood pressure monitoring	4 weeks after hospital discharge
Primary	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
Primary	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	Clinic blood pressure measurement in mmHg	Documented in the patient documentation	At baseline
Secondary	Research blood pressure measurement in mmHg	Standardized blood pressure measurement taken by research staff	At baseline
Secondary	Prevalence of previously unknown arterial hypertension	No previously documented diagnosis of arterial hypertension and no antihypertensive treatment	At baseline
Secondary	Prevalence of female gender	As reported by participant	At baseline
Secondary	Prevalence of re-hospitalization for any cause	According to hospital documentation and patient interrogation	Until 4 weeks after hospital discharge