Status:
RECRUITING
Home Blood Pressure Monitoring in Kidney Transplant Recipients
Lead Sponsor:
Oslo University Hospital
Conditions:
Hypertension
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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. Th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT04364126
Start Date
December 15 2022
End Date
August 1 2026
Last Update
April 3 2024
Active Locations (1)
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1
Oslo University Hospital, Rikshospitalet
Oslo, Norway