Home Blood Pressure Monitoring in Kidney Transplant Recipients (HOBiT)

University of Oslo (UIO)

Status: Terminated

Conditions: Hypertension; Kidney Transplant; Complications; Cardiovascular Diseases

Treatments: Device: Home blood pressure apparatus; Other: Clinic blood pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT04364126

109164

Details and patient eligibility

About

Randomized controlled study of home blood pressure monitoring in kidney transplant recipients.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Standard of care

Active Comparator group

Description:

Clinical blood pressure measured at regular visits

Treatment:

Other: Clinic blood pressure

Home blood pressure monitoring

Experimental group

Description:

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

Treatment:

Device: Home blood pressure apparatus