Cardiovascular Diseases, Hypertension, Kidney Transplant; Complications
Conditions
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.
Interventions
DEVICEHome blood pressure apparatus
Target \<125/80 mmHg
OTHERClinic blood pressure
Target \<130/80 mmHg
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized 1:1 parallel group study with baseline and follow-up measurements
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Office systolic blood pressure (BP) | 1 year | As reported to Norwegian Renal Registry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Office diastolic BP | 1 year | As reported to Norwegian Renal Registry |
| 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 |
| Treatment satisfaction | 1 year | According to study-specific questionnaire in Norwegian. Scores of 1-5, higher scores indicating higher satisfaction. |
| Concentration of plasma creatinine | 1 year | As reported to Norwegian Renal Registry |
| Urine protein/creatinine ratio | 1 year | As reported to Norwegian Renal Registry |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORDag Olav Dahle, MD PhD
Oslo University Hospital
Outcome results
None listed