Clinical trial NCT04364126: Home Blood Pressure Monitoring in Kidney Transplant Recipients
Official title: Home Blood Pressure Monitoring in Kidney Transplant Recipients to Alleviate Hypertension - a Pragmatic, Registry-based, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Cardiovascular Diseases
Kidney Transplant; Complications
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized 1:1 parallel group study with baseline and follow-up measurements
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Office systolic blood pressure (BP)
timeFrame: 1 year
Secondary outcomes:
measure: Office diastolic BP
timeFrame: 1 year
measure: Proportion with BP below target (office BP <130/80 mmHg)
timeFrame: 1 year
measure: Number of BP lowering medications
timeFrame: 1 year
measure: Treatment satisfaction
timeFrame: 1 year
measure: Concentration of plasma creatinine
timeFrame: 1 year
measure: Urine protein/creatinine ratio
timeFrame: 1 year
Other outcomes:
measure: Number of patients with cardiovascular events
timeFrame: 1 year
measure: Number of participants with kidney graft loss
timeFrame: 1 year
measure: Number of participants with kidney graft rejection
timeFrame: 1 year
measure: Number of deaths
timeFrame: 1 year
measure: Overall quality of life
timeFrame: 1 year
measure: Hypotensive episodes
timeFrame: 1 year
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
Study officials:
affiliation: Oslo University Hospital
name: Dag Olav Dahle, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: