HypertensionHOBiTNCT04364126
Home Blood Pressure Monitoring in Kidney Transplant Recipients
A study testing Home blood pressure apparatus and Clinic blood pressure in people with Hypertension and Cardiovascular Diseases, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Randomized controlled study of home blood pressure monitoring in kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Cardiovascular Diseases, Kidney Transplant; Complications
- What is being tested?
- Home blood pressure apparatus and Clinic blood pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNorway
- Study dates
- 15 Dec 2022to 1 Jan 2026
- 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
- Kidney transplant recipient
- Male or female subject ≥ 18 years old
- Any or more of the following at the baseline clinic
- Conventional office BP ≥130 mmHg systolic and/or ≥ 80 mmHg diastolic
- HBPM ≥125 mmHg systolic and/or ≥ 80 mmHg diastolic measured within the last 3 months (see appendix 1 for details on methodology)
- Daytime ambulatory blood pressure monitoring (ABPM) ≥125 mmHg systolic and/or ≥ 80 mmHg diastolic measured within the last 3 months
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- Signed informed consent and expected cooperation of the patient for the treatment and follow up.
- Have a national personal identification number and not be expected to emigrate during study
- Enlisted in the Norwegian Renal Registry
Who cannot join
- Standing systolic BP < 110 mmHg (to avoid adverse events). Measured after one and three minutes of standing. Not applicable if unable to stand due to wheelchair use.
- Diagnosed atrial fibrillation (automated monitors not validated)
- Unwilling to self-monitor
- Female participant who is pregnant, lactating or planning pregnancy during the trial (management of essential hypertension in pregnancy is different)
- Arm circumference too large or small to allow accurate BP measurement with available device (22-42 cm).
- Any reason likely limiting adherence to interventions, as judged by the investigator; examples include active alcohol or substance abuse within the last 12 months, significant poor compliance with medications or attendance at clinic visits, residence in a nursing home, dementia, other medical or psychiatric conditions that may interfere with study participation.
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- Graft- or life expectancy less than 2 years, as judged by the investigator.
- Current use of ≥ 4 antihypertensive medications
- More than half of regular appointments planned as remote (e.g. phone or video) consultations.
- Severe white-coat hypertension, e.g. patients already treated solely based on home BP values.
- Multi-organ transplants (e.g. heart, lung, liver), though pancreas or beta-cell islet transplant is allowed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home Blood Pressure Monitoring in Kidney Transplant Recipients to Alleviate Hypertension - a Pragmatic, Registry-based, Randomized Controlled Study
Randomized controlled study of home blood pressure monitoring in kidney transplant recipients.
Read the detailed description
Adult kidney transplant recipients (n=458) will be randomized 1:1 to standard-of-care (SOC) or home blood pressure measurement (HBPM). The SOC group will target office blood pressure <130/80 mmHg. The HBPM group will measure BP at home, twice morning and evening for (3-)7 days before routine clinical visits (ideally 28 measurements); the mean value from day 2-7 is used; target home mean BP is < 125/80 mmHg.
- Being tested
- Home blood pressure apparatus, Clinic blood pressure
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home blood pressure apparatusDevice
Target <125/80 mmHg
Clinic blood pressureOther
Target <130/80 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Clinical blood pressure measured at regular visits Receives: Other: Clinic blood pressure |
| Home blood pressure monitoring | Experimental | Home blood pressure measured daily for 1 week before regular clinical visits Receives: Device: Home blood pressure apparatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Office systolic blood pressure (BP)
As reported to Norwegian Renal Registry
Measured: 1 year
Secondary outcomes (6)
Office diastolic BP
As reported to Norwegian Renal Registry
Measured: 1 year
Proportion with BP below target (office BP <130/80 mmHg)
As reported to Norwegian Renal Registry
Measured: 1 year
Number of BP lowering medications
As reported to Norwegian Renal Registry
Measured: 1 year
Treatment satisfaction
According to study-specific questionnaire in Norwegian. Scores of 1-5, higher scores indicating higher satisfaction.
Measured: 1 year
Concentration of plasma creatinine
As reported to Norwegian Renal Registry
Measured: 1 year
Urine protein/creatinine ratio
As reported to Norwegian Renal Registry
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start15 Dec 2022
- Primary completion3 Feb 2025
- Study completion1 Jan 2026
Why it stopped: Slow recruitment
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.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1 parallel group study with baseline and follow-up measurements
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dag Olav Dahle, Oslo University Hospital
- Investigators
- Dag Olav Dahle, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364126
- Sponsor's protocol ID
- 109164
- Acronym
- HOBiT
- Status last verified
- Jan 2026
- First submitted
- 22 Apr 2020
- Last updated
- 21 Jan 2026
- 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Blood Pressure Monitoring in Kidney Transplant Recipients to Alleviate Hypertension - a Pragmatic, Registry-based, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04364126
- Acronym / sponsor ID
- HOBiT / 109164
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 27 Apr 2020 (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.
Randomized controlled study of home blood pressure monitoring in kidney transplant recipients.
Detailed description
Adult kidney transplant recipients (n=458) will be randomized 1:1 to standard-of-care (SOC) or home blood pressure measurement (HBPM). The SOC group will target office blood pressure <130/80 mmHg. The HBPM group will measure BP at home, twice morning and evening for (3-)7 days before routine clinical visits (ideally 28 measurements); the mean value from day 2-7 is used; target home mean BP is < 125/80 mmHg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized 1:1 parallel group study with baseline and follow-up measurements
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: Clinic blood pressureClinical blood pressure measured at regular visits |
| Home blood pressure monitoring | Experimental | Device: Home blood pressure apparatusHome blood pressure measured daily for 1 week before regular clinical visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Kidney transplant recipient
- Male or female subject ≥ 18 years old
- Any or more of the following at the baseline clinic
- Signed informed consent and expected cooperation of the patient for the treatment and follow up.
- Have a national personal identification number and not be expected to emigrate during study
Key exclusion criteria (11 listed)
- Standing systolic BP < 110 mmHg (to avoid adverse events). Measured after one and three minutes of standing. Not applicable if unable to stand due to wheelchair use.
- Diagnosed atrial fibrillation (automated monitors not validated)
- Unwilling to self-monitor
- Female participant who is pregnant, lactating or planning pregnancy during the trial (management of essential hypertension in pregnancy is different)
- Arm circumference too large or small to allow accurate BP measurement with available device (22-42 cm).
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 |
|---|---|---|
| Home blood pressure apparatusTarget <125/80 mmHg | Device | Home blood pressure monitoring |
| Clinic blood pressureTarget <130/80 mmHg | Other | Standard of care |
Primary outcome
Office systolic blood pressure (BP)
Time frame: 1 year
As reported to Norwegian Renal Registry
6 secondary outcomes
Office diastolic BP
Time frame: 1 year
Proportion with BP below target (office BP <130/80 mmHg)
Time frame: 1 year
Number of BP lowering medications
Time frame: 1 year
Treatment satisfaction
Time frame: 1 year
Concentration of plasma creatinine
Time frame: 1 year
Urine protein/creatinine ratio
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- 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.
Dag Olav Dahle, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home blood pressure apparatus and Clinic blood pressure in people with Hypertension and Cardiovascular Diseases, run by Oslo University Hospital at 1 site in Norway.
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 9 inclusion and 11 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: stopped early, as of the sponsor's last update on 21 Jan 2026. 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 Norway. 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?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Office systolic blood pressure (BP) (time frame: 1 year). 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 21 Jan 2026.