INDEBP: In-Hospital Detection of Elevated Blood Pressure

Sponsor

Annina Vischer (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06132451

Collaborator

(none)

800

Enrollment

Arms

13.8

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Blood Pressure, High	Other: Postponement of antihypertensive treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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 (Care Provider)

Masking Description:

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.

Primary Purpose:

Diagnostic

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

Anticipated Study Start Date :

Nov 7, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Annina Vischer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Annina Vischer, Principle Investigator, University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT06132451

Other Study ID Numbers:

INDEBP-prospective
2023-01566

First Posted:

Nov 15, 2023

Last Update Posted:

Nov 15, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Annina Vischer, Principle Investigator, University Hospital, Basel, Switzerland

arterial hypertension

elevated blood pressure

ambulatory blood pressure measurement

antihypertensive medication

Additional relevant MeSH terms:

Hypertension

Antihypertensive Agents

Study Results

No Results Posted as of Nov 15, 2023