NCT04364126RecruitingNot Applicable
Home Blood Pressure Monitoring in Kidney Transplant Recipients to Alleviate Hypertension - a Pragmatic, Registry-based, Randomized Controlled Study
Oslo University Hospital1 site in 1 country458 target enrollmentStarted: December 15, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 458
- Locations
- 1
- Primary Endpoint
- Office systolic blood pressure (BP)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Standard of care
Active Comparator
Clinical blood pressure measured at regular visits
Intervention: Clinic blood pressure (Other)
Home blood pressure monitoring
Experimental
Home blood pressure measured daily for 1 week before regular clinical visits
Intervention: Home blood pressure apparatus (Device)
Outcomes
Primary Outcomes
Office systolic blood pressure (BP)
Time Frame: 1 year
As reported to Norwegian Renal Registry
Secondary Outcomes
- Number of BP lowering medications(1 year)
- Concentration of plasma creatinine(1 year)
- Office diastolic BP(1 year)
- Treatment satisfaction(1 year)
- Urine protein/creatinine ratio(1 year)
- Proportion with BP below target (office BP <130/80 mmHg)(1 year)
Investigators
Dag Olav Dahle
Principal Investigator
Oslo University Hospital
Study Sites (1)
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