HypertensionINDEBPNCT06132451
In-Hospital Detection of Elevated Blood Pressure
A study testing Postponement of antihypertensive treatment in people with Hypertension and Blood Pressure, High, run by Annina Vischer at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Blood Pressure, High
- What is being tested?
- Postponement of antihypertensive treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Nov 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Annina Vischer, M.D., +41612652525, annina.vischer@usb.ch
About this study
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
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
- Being tested
- Postponement of antihypertensive treatment
- Keywords
- arterial hypertension, elevated blood pressure, ambulatory blood pressure measurement, antihypertensive medication
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postponement of antihypertensive treatmentOther
Hypertensive blood pressure values in medical in-patients will not be treated during hospitalisation until confirmed by ABPM 4 weeks after hospital discharge
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Postponement of antihypertensive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of persisting new or uncontrolled arterial hypertension
Elevated blood pressure values in ambulatory blood pressure monitoring
Measured: 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
Measured: 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
Measured: Until 4 weeks after hospital discharge
Secondary outcomes (5)
Clinic blood pressure measurement in mmHg
Documented in the patient documentation
Measured: At baseline
Research blood pressure measurement in mmHg
Standardized blood pressure measurement taken by research staff
Measured: At baseline
Prevalence of previously unknown arterial hypertension
No previously documented diagnosis of arterial hypertension and no antihypertensive treatment
Measured: At baseline
Prevalence of female gender
As reported by participant
Measured: At baseline
Prevalence of re-hospitalization for any cause
According to hospital documentation and patient interrogation
Measured: Until 4 weeks after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start16 Nov 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Annina Vischer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Annina Vischer, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132451
- Sponsor's protocol ID
- INDEBP-prospective
- Other IDs
- 2023-01566, 2023
- Acronym
- INDEBP
- Status last verified
- Sep 2024
- First submitted
- 5 Nov 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06132451
- Acronym / sponsor ID
- INDEBP / INDEBP-prospective
- Conditions
- Hypertension, Blood Pressure, High
- Keywords
- arterial hypertension, elevated blood pressure, ambulatory blood pressure measurement, antihypertensive medication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Annina VischerUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual practice arm | No intervention | –Patients will be treated according to their treating physicians' decision. |
| Postponement of treatment arm | Other | Other: Postponement of antihypertensive treatmentAntihypertensive treatment adaptions will be postponed until after a 24h ambulatory blood pressure measurement (ABPM) 4 weeks after hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postponement of antihypertensive treatmentHypertensive blood pressure values in medical in-patients will not be treated during hospitalisation until confirmed by ABPM 4 weeks after hospital discharge | Other | Postponement of treatment arm |
Primary outcome
Prevalence of persisting new or uncontrolled arterial hypertension
Time frame: 4 weeks after hospital discharge
Elevated blood pressure values in ambulatory blood pressure monitoring
Prevalence of a combined hypertensive complication endpoint
Time frame: 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
Time frame: 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
5 secondary outcomes
Clinic blood pressure measurement in mmHg
Time frame: At baseline
Research blood pressure measurement in mmHg
Time frame: At baseline
Prevalence of previously unknown arterial hypertension
Time frame: At baseline
Prevalence of female gender
Time frame: At baseline
Prevalence of re-hospitalization for any cause
Time frame: Until 4 weeks after hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postponement of antihypertensive treatment in people with Hypertension and Blood Pressure, High, run by Annina Vischer at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annina Vischer, M.D. (+41612652525, annina.vischer@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of persisting new or uncontrolled arterial hypertension (time frame: 4 weeks after hospital discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.