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TerminatedNCT04364126HOBiTUpdated Jan 21, 2026

Home Blood Pressure Monitoring in Kidney Transplant Recipients

An interventional study of Home blood pressure apparatus and Clinic blood pressure in Hypertension, Cardiovascular Diseases and Kidney Transplant; Complications, sponsored by Oslo University Hospital. Terminated at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment

Why this study was terminated
Slow recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hypertension
  • Cardiovascular Diseases
  • Kidney Transplant; Complications
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 21 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Kidney transplant recipient
  2. Male or female subject ≥ 18 years old
  3. 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
  4. Signed informed consent and expected cooperation of the patient for the treatment and follow up.
  5. Have a national personal identification number and not be expected to emigrate during study
  6. Enlisted in the Norwegian Renal Registry

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Diagnosed atrial fibrillation (automated monitors not validated)
  3. Unwilling to self-monitor
  4. Female participant who is pregnant, lactating or planning pregnancy during the trial (management of essential hypertension in pregnancy is different)
  5. Arm circumference too large or small to allow accurate BP measurement with available device (22-42 cm).
  6. 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.
  7. Graft- or life expectancy less than 2 years, as judged by the investigator.
  8. Current use of ≥ 4 antihypertensive medications
  9. More than half of regular appointments planned as remote (e.g. phone or video) consultations.
  10. Severe white-coat hypertension, e.g. patients already treated solely based on home BP values.
  11. Multi-organ transplants (e.g. heart, lung, liver), though pancreas or beta-cell islet transplant is allowed.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Active comparator
    Standard of care

    Clinical blood pressure measured at regular visits

    Other: Clinic blood pressure

  • Experimental
    Home blood pressure monitoring

    Home blood pressure measured daily for 1 week before regular clinical visits

    Device: Home blood pressure apparatus

Interventions

  • DeviceHome blood pressure apparatus

    Target \<125/80 mmHg

  • OtherClinic blood pressure

    Target \<130/80 mmHg

06

What researchers measure

Primary outcomes

  1. Office systolic blood pressure (BP)

    As reported to Norwegian Renal Registry

    Time frame: 1 year

Secondary outcomes

  1. Office diastolic BP

    As reported to Norwegian Renal Registry

    Time frame: 1 year

  2. Proportion with BP below target (office BP <130/80 mmHg)

    As reported to Norwegian Renal Registry

    Time frame: 1 year

  3. Number of BP lowering medications

    As reported to Norwegian Renal Registry

    Time frame: 1 year

  4. Treatment satisfaction

    According to study-specific questionnaire in Norwegian. Scores of 1-5, higher scores indicating higher satisfaction.

    Time frame: 1 year

  5. Concentration of plasma creatinine

    As reported to Norwegian Renal Registry

    Time frame: 1 year

  6. Urine protein/creatinine ratio

    As reported to Norwegian Renal Registry

    Time frame: 1 year

Other outcomes

  1. Number of patients with cardiovascular events

    As reported to the Norwegian Renal Registry. Safety endpoint. Includes myocardial infarction, stroke, coronary artery bypass grafting or -angioplasty, other cardiac surgery.

    Time frame: 1 year

  2. Number of participants with kidney graft loss

    As reported to the Norwegian Renal RegistrySafety. Safety endpoint. Includes return to dialysis or re-transplant.

    Time frame: 1 year

  3. Number of participants with kidney graft rejection

    As reported to Norwegian Renal Registry. Safety endpoint.

    Time frame: 1 year

  4. Number of deaths

    As reported to Norwegian Renal Registry. Safety endpoint

    Time frame: 1 year

  5. Overall quality of life

    According to study-specific questionnaire in Norwegian. Scores of 1-5, higher scores indicating higher quality of life.

    Time frame: 1 year

  6. Hypotensive episodes

    According to study-specific questionnaire in Norwegian. Self-reported safety endpoint. Questions about A) Pre-syncope (3 categories: never; a few; montly or more); B) Syncope (3 categories: never; once; multiple). C) If syncope, free text if any trauma was experienced.

    Time frame: 1 year

07

Study locations

1 site
  • Oslo University Hospital, Rikshospitalet
    Oslo, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04364126
Lead sponsor
Oslo University Hospital
Responsible party
Dag Olav Dahle (Principal Investigator, Oslo University Hospital) — Principal investigator
First posted
Apr 27, 2020
Start date
Dec 15, 2022
Primary completion
Feb 3, 2025
Completion
Jan 1, 2026
Last update
Jan 21, 2026

Study contacts

Dag Olav Dahle, MD PhD
principal investigator · Oslo University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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