Home Blood Pressure Monitoring in Kidney Transplant Recipients

NCT04364126 | Terminated

• 1 other identifier: 109164
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension; Cardiovascular Diseases; Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• Office systolic blood pressure (BP)

  As reported to Norwegian Renal Registry

  1 year

Secondary Outcomes (6)

• Office diastolic BP

  1 year

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

  1 year

• Number of BP lowering medications

  1 year

• Treatment satisfaction

  1 year

• Concentration of plasma creatinine

  1 year

Other Outcomes (6)

• Number of patients with cardiovascular events

  1 year

• Number of participants with kidney graft loss

  1 year

• Number of participants with kidney graft rejection

  1 year

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Clinical blood pressure measured at regular visits

Other: Clinic blood pressure

Home blood pressure monitoring

EXPERIMENTAL

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

Device: Home blood pressure apparatus

Interventions

Home blood pressure apparatus DEVICE

Target \<125/80 mmHg

Home blood pressure monitoring

Clinic blood pressure OTHER

Target \<130/80 mmHg

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Rikshospitalet

Oslo, Norway

Location

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Dag Olav Dahle, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized 1:1 parallel group study with baseline and follow-up measurements

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 27, 2020
• Study Start: December 15, 2022
• Primary Completion: February 3, 2025
• Study Completion: January 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)