Monitoring blood pressure at home for kidney transplant patients
Home Blood Pressure Monitoring in Kidney Transplant Recipients to Alleviate Hypertension - a Pragmatic, Registry-based, Randomized Controlled Study
This study is testing if kidney transplant patients who monitor their blood pressure at home can lower their blood pressure better than those who only have it checked at the clinic.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 458 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT04364126 on ClinicalTrials.gov |
What this trial studies
This study involves a randomized controlled trial with 458 adult kidney transplant recipients who will be assigned to either standard-of-care or home blood pressure monitoring. The standard group will have their blood pressure managed during clinic visits, while the home monitoring group will measure their blood pressure twice daily for a week before clinical visits. The goal is to achieve a lower target blood pressure in the home monitoring group compared to the standard care group, potentially leading to better management of hypertension and cardiovascular risks in these patients.
Who should consider this trial
Good fit: Ideal candidates are adult kidney transplant recipients aged 18 and older with elevated blood pressure readings.
Not a fit: Patients with standing systolic blood pressure below 110 mmHg or diagnosed atrial fibrillation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved blood pressure control and reduced cardiovascular complications in kidney transplant recipients.
How similar studies have performed: Other studies have shown that home blood pressure monitoring can improve hypertension management, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oslo
- Oslo University Hospital, Rikshospitalet — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Dag Olav Dahle, MD PhD — Oslo University Hospital
- Study coordinator: Dag Olav Dahle, MD PhD
- Email: dagdah@ous-hf.no
- Phone: +4723070000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.