Overview
Randomized controlled study of home blood pressure monitoring in kidney transplant recipients.
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.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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.