Home Blood Pressure Monitoring in Kidney Transplant Recipients

Not Applicable

Recruiting

• Conditions: Hypertension; Kidney Transplant; Complications; Cardiovascular Diseases
• Interventions: Other: Clinic blood pressure; Device: Home blood pressure apparatus

• Registration Number: NCT04364126
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-27
• Study Start: 2022-12-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 458

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Clinic blood pressure	Clinical blood pressure measured at regular visits
Home blood pressure monitoring	Home blood pressure apparatus	Home blood pressure measured daily for 1 week before regular clinical visits

Primary Outcome Measures

Name	Time	Method
Office systolic blood pressure (BP)	1 year	As reported to Norwegian Renal Registry

Secondary Outcome Measures

Name	Time	Method
Proportion with BP below target (office BP <130/80 mmHg)	1 year	As reported to Norwegian Renal Registry
Number of BP lowering medications	1 year	As reported to Norwegian Renal Registry
Concentration of plasma creatinine	1 year	As reported to Norwegian Renal Registry
Office diastolic BP	1 year	As reported to Norwegian Renal Registry
Treatment satisfaction	1 year	According to study-specific questionnaire in Norwegian. Scores of 1-5, higher scores indicating higher satisfaction.
Urine protein/creatinine ratio	1 year	As reported to Norwegian Renal Registry

Trial Locations

Locations (1)

Oslo University Hospital, Rikshospitalet; 🇳🇴 Oslo, Norway