Home Blood Pressure Monitoring in Kidney Transplant Recipients

NCT ID: NCT04364126

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2026-01-01

Brief Summary

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.

Conditions

Hypertension; Cardiovascular Diseases; Kidney Transplant; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of care

Clinical blood pressure measured at regular visits

Group Type: ACTIVE_COMPARATOR

Clinic blood pressure

Intervention Type: OTHER

Target \<130/80 mmHg

Home blood pressure monitoring

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

Group Type: EXPERIMENTAL

Home blood pressure apparatus

Intervention Type: DEVICE

Target \<125/80 mmHg

Interventions

Home blood pressure apparatus

Target \<125/80 mmHg

Intervention Type: DEVICE

Clinic blood pressure

Target \<130/80 mmHg

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dag Olav Dahle

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dag Olav Dahle, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Countries

Norway

Other Identifiers

109164

Identifier Type: -

Identifier Source: org_study_id