Home Blood Pressure Monitoring in Kidney Transplant Recipients

Hypertension Clinical Trial

— HOBiT  

Official title:

Home Blood Pressure Monitoring in Kidney Transplant Recipients to Alleviate Hypertension - a Pragmatic, Registry-based, Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04364126
• Other study ID #: 109164
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: Oslo University Hospital
• Contact: Dag Olav Dahle, MD PhD
• Phone: +4723070000
• Email: dagdah[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 458
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension
• Kidney Transplant; Complications

Intervention

Device:
• Home blood pressure apparatus
Target <125/80 mmHg

Other:
• Clinic blood pressure
Target <130/80 mmHg

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with cardiovascular events	As reported to the Norwegian Renal Registry. Safety endpoint. Includes myocardial infarction, stroke, coronary artery bypass grafting or -angioplasty, other cardiac surgery.	1 year
Other	Number of participants with kidney graft loss	As reported to the Norwegian Renal RegistrySafety. Safety endpoint. Includes return to dialysis or re-transplant.	1 year
Other	Number of participants with kidney graft rejection	As reported to Norwegian Renal Registry. Safety endpoint.	1 year
Other	Number of deaths	As reported to Norwegian Renal Registry. Safety endpoint	1 year
Other	Overall quality of life	According to study-specific questionnaire in Norwegian. Scores of 1-5, higher scores indicating higher quality of life.	1 year
Other	Hypotensive episodes	According to study-specific questionnaire in Norwegian. Self-reported safety endpoint. Questions about A) Pre-syncope (3 categories: never; a few; montly or more); B) Syncope (3 categories: never; once; multiple). C) If syncope, free text if any trauma was experienced.	1 year
Primary	Office systolic blood pressure (BP)	As reported to Norwegian Renal Registry	1 year
Secondary	Office diastolic BP	As reported to Norwegian Renal Registry	1 year
Secondary	Proportion with BP below target (office BP <130/80 mmHg)	As reported to Norwegian Renal Registry	1 year
Secondary	Number of BP lowering medications	As reported to Norwegian Renal Registry	1 year
Secondary	Treatment satisfaction	According to study-specific questionnaire in Norwegian. Scores of 1-5, higher scores indicating higher satisfaction.	1 year
Secondary	Concentration of plasma creatinine	As reported to Norwegian Renal Registry	1 year
Secondary	Urine protein/creatinine ratio	As reported to Norwegian Renal Registry	1 year