In-Hospital Detection of Elevated Blood Pressure

NCT06132451 | Recruiting

• 2 other identifiers: INDEBP-prospective2023-01566
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Blood Pressure, High

Keywords

arterial hypertension; elevated blood pressure; ambulatory blood pressure measurement; antihypertensive medication

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Clinic blood pressure measurement in mmHg

  At baseline

• Research blood pressure measurement in mmHg

  At baseline

• Prevalence of previously unknown arterial hypertension

  At baseline

• Prevalence of female gender

  At baseline

• Prevalence of re-hospitalization for any cause

  Until 4 weeks after hospital discharge

Study Arms (2)

Usual practice arm

NO INTERVENTION

Patients will be treated according to their treating physicians' decision.

Postponement of treatment arm

OTHER

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

Interventions

Postponement of antihypertensive treatment OTHER

Hypertensive blood pressure values in medical in-patients will not be treated during hospitalisation until confirmed by ABPM 4 weeks after hospital discharge

Postponement of treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Annina Vischer: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Annina Vischer, M.D.

CONTACT

+41612652525; annina.vischer@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: In the first block, the treating physicians will not be informed about the study participation of their patient, in order to ensure that they will treat the patient according to what they perceive as the current usual practice. In the second block, the treating physicians will be informed about the study participation of their patients.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 15, 2023
• Study Start: November 16, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)