Home Blood Pressure Monitoring in Kidney Transplant Recipients (HOBiT)

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

Randomized controlled study of home blood pressure monitoring in kidney transplant recipients.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Hypertension; Kidney Transplant; Complications
• Intervention / Treatment: Other: Clinic blood pressure; Device: Home blood pressure apparatus

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 Type: Interventional
• Enrollment (Estimated): 458
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dag Olav Dahle, MD PhD; Phone Number: +4723070000; Email: dagdah@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital, Rikshospitalet
    • Contact: Dag Olav Dahle, MD PhD; Phone Number: +4723070000; Email: dagdah@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care; Clinical blood pressure measured at regular visits	Other: Clinic blood pressure; Target <130/80 mmHg
Experimental: Home blood pressure monitoring; Home blood pressure measured daily for 1 week before regular clinical visits	Device: Home blood pressure apparatus; Target <125/80 mmHg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Office systolic blood pressure (BP)	As reported to Norwegian Renal Registry	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Office diastolic BP	As reported to Norwegian Renal Registry	1 year
Proportion with BP below target (office BP <130/80 mmHg)	As reported to Norwegian Renal Registry	1 year
Number of BP lowering medications	As reported to Norwegian Renal Registry	1 year
Treatment satisfaction	According to study-specific questionnaire in Norwegian. Scores of 1-5, higher scores indicating higher satisfaction.	1 year
Concentration of plasma creatinine	As reported to Norwegian Renal Registry	1 year
Urine protein/creatinine ratio	As reported to Norwegian Renal Registry	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Number of participants with kidney graft rejection	As reported to Norwegian Renal Registry. Safety endpoint.	1 year
Number of deaths	As reported to Norwegian Renal Registry. Safety endpoint	1 year
Overall quality of life	According to study-specific questionnaire in Norwegian. Scores of 1-5, higher scores indicating higher quality of life.	1 year
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Dag Olav Dahle, MD PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Hypertension; Cardiovascular Diseases
• Other Study ID Numbers: 109164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No