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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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