Back to resultsHome Blood Pressure Monitoring in Kidney Transplant Recipients (HOBiT)
Primary Purpose
Hypertension, Cardiovascular Diseases, Kidney Transplant; Complications
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Home blood pressure apparatus
Clinic blood pressure
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
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.
Sites / Locations
- Oslo University Hospital, RikshospitaletRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of care
Home blood pressure monitoring
Arm Description
Clinical blood pressure measured at regular visits
Home blood pressure measured daily for 1 week before regular clinical visits
Outcomes
Primary Outcome Measures
Office systolic blood pressure (BP)
As reported to Norwegian Renal Registry
Secondary Outcome Measures
Office diastolic BP
As reported to Norwegian Renal Registry
Proportion with BP below target (office BP <130/80 mmHg)
As reported to Norwegian Renal Registry
Number of BP lowering medications
As reported to Norwegian Renal Registry
Treatment satisfaction
According to study-specific questionnaire in Norwegian. Scores of 1-5, higher scores indicating higher satisfaction.
Concentration of plasma creatinine
As reported to Norwegian Renal Registry
Urine protein/creatinine ratio
As reported to Norwegian Renal Registry
Full Information
NCT ID
NCT04364126
First Posted
April 22, 2020
Last Updated
December 20, 2022
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04364126
Brief Title
Home Blood Pressure Monitoring in Kidney Transplant Recipients
Acronym
HOBiT
Official Title
Home Blood Pressure Monitoring in Kidney Transplant Recipients to Alleviate Hypertension - a Pragmatic, Registry-based, Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Cardiovascular Diseases, Kidney Transplant; Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized 1:1 parallel group study with baseline and follow-up measurements
Masking
None (Open Label)
Allocation
Randomized
Enrollment
458 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Clinical blood pressure measured at regular visits
Arm Title
Home blood pressure monitoring
Arm Type
Experimental
Arm Description
Home blood pressure measured daily for 1 week before regular clinical visits
Intervention Type
Device
Intervention Name(s)
Home blood pressure apparatus
Intervention Description
Target <125/80 mmHg
Intervention Type
Other
Intervention Name(s)
Clinic blood pressure
Intervention Description
Target <130/80 mmHg
Primary Outcome Measure Information:
Title
Office systolic blood pressure (BP)
Description
As reported to Norwegian Renal Registry
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Office diastolic BP
Description
As reported to Norwegian Renal Registry
Time Frame
1 year
Title
Proportion with BP below target (office BP <130/80 mmHg)
Description
As reported to Norwegian Renal Registry
Time Frame
1 year
Title
Number of BP lowering medications
Description
As reported to Norwegian Renal Registry
Time Frame
1 year
Title
Treatment satisfaction
Description
According to study-specific questionnaire in Norwegian. Scores of 1-5, higher scores indicating higher satisfaction.
Time Frame
1 year
Title
Concentration of plasma creatinine
Description
As reported to Norwegian Renal Registry
Time Frame
1 year
Title
Urine protein/creatinine ratio
Description
As reported to Norwegian Renal Registry
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Number of patients with cardiovascular events
Description
As reported to the Norwegian Renal Registry. Safety endpoint. Includes myocardial infarction, stroke, coronary artery bypass grafting or -angioplasty, other cardiac surgery.
Time Frame
1 year
Title
Number of participants with kidney graft loss
Description
As reported to the Norwegian Renal RegistrySafety. Safety endpoint. Includes return to dialysis or re-transplant.
Time Frame
1 year
Title
Number of participants with kidney graft rejection
Description
As reported to Norwegian Renal Registry. Safety endpoint.
Time Frame
1 year
Title
Number of deaths
Description
As reported to Norwegian Renal Registry. Safety endpoint
Time Frame
1 year
Title
Overall quality of life
Description
According to study-specific questionnaire in Norwegian. Scores of 1-5, higher scores indicating higher quality of life.
Time Frame
1 year
Title
Hypotensive episodes
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dag Olav Dahle, MD PhD
Phone
+4723070000
Email
dagdah@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dag Olav Dahle, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, Rikshospitalet
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dag Olav Dahle, MD PhD
Phone
+4723070000
Email
dagdah@ous-hf.no
12. IPD Sharing Statement
Plan to Share IPD
No
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Home Blood Pressure Monitoring in Kidney Transplant Recipients
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