Home Blood Pressure (HBP)-Guided Management of Hypertension in Stage 3-4 CKD
NCT ID: NCT03588520
Last Updated: 2022-02-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
70 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-06-02
Study Completion Date
2022-09-30
Brief Summary
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It is estimated that over 25% of the world's population had hypertension in the year 2000 and that this proportion will reach 30% in the year 2025. With the introduction of the 2017 Guideline for High Blood Pressure in Adults from the American College of Cardiology and the American Heart Association Task Force on Clinical Practice Guidelines, the definition of hypertension became broader and as a result the prevalence is expected to further increase. On the other hand, it is estimated that around 10% of the world's population is affected by chronic kidney disease (CKD) with hypertension being both cause and complication of CKD.
It is obvious that hypertension and CKD are interconnected and are both major risk factors for cardiovascular disease (CVD). Hypertension results in increased CVD risk both directly, as an independent factor, and indirectly via its negative impact on renal function. In fact, the deterioration of the renal function is proportional to the degree of hypertension. On the other hand, the more advanced the CKD is, the more challenging the management of hypertension becomes, as patients with CKD present altered patterns of blood pressure (BP) during the day and, additionally, the prevalence of white coat and masked hypertension is significantly higher in this group of patients.
To date, hypertensive patients are treated according to the BP recordings that are obtained in the office (OBP) during routine patient visits, which leads to inaccurate estimates of the true burden of hypertension and also affects the efficacy of the therapeutic intervention. It has been suggested that self measured BP (HBP) is a more accurate estimate of the patients' daytime BP compared to the conventional office BP measurements. This has been already confirmed in studies regarding the general population and it has been suggested that the same applies to the patients with CKD. This study aims to check the validity of this hypothesis by comparing the effect of the HBP - guided management versus the conventional OBP - guided management on the 24 hour ambulatory BP monitoring of patients with uncontrolled hypertension and CKD stage 3 and 4.
It is obvious that hypertension and CKD are interconnected and are both major risk factors for cardiovascular disease (CVD). Hypertension results in increased CVD risk both directly, as an independent factor, and indirectly via its negative impact on renal function. In fact, the deterioration of the renal function is proportional to the degree of hypertension. On the other hand, the more advanced the CKD is, the more challenging the management of hypertension becomes, as patients with CKD present altered patterns of blood pressure (BP) during the day and, additionally, the prevalence of white coat and masked hypertension is significantly higher in this group of patients.
To date, hypertensive patients are treated according to the BP recordings that are obtained in the office (OBP) during routine patient visits, which leads to inaccurate estimates of the true burden of hypertension and also affects the efficacy of the therapeutic intervention. It has been suggested that self measured BP (HBP) is a more accurate estimate of the patients' daytime BP compared to the conventional office BP measurements. This has been already confirmed in studies regarding the general population and it has been suggested that the same applies to the patients with CKD. This study aims to check the validity of this hypothesis by comparing the effect of the HBP - guided management versus the conventional OBP - guided management on the 24 hour ambulatory BP monitoring of patients with uncontrolled hypertension and CKD stage 3 and 4.
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Detailed Description
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Hypertension among people with chronic kidney disease (CKD) is very common, difficult to diagnose and often poorly controlled. The identification and management of hypertension among patients with CKD is challenging, owing to the markedly altered patterns and rhythms of blood pressure (BP) during the 24-hour period (i.e., non-dipping status and nocturnal hypertension) and the high prevalence of white coat and masked hypertension in these individuals. Conventional BP recordings obtained in the office are reported to provide inaccurate estimates of the true BP burden assessed using out-of-office BP monitoring techniques. Self-measured BP by the patients themselves at home provides a more accurate estimate of the patient's daytime BP. Similarly to the general hypertensive population, clinical studies support the notion that among people with CKD, home BP monitoring offers several advantages over the conventional office BP recordings in diagnosing hypertension and estimating the associated cardiovascular and renal risk. Compared with office BP, home BP recordings exhibit closer association with indices of target-organ damage, such as left ventricular mass index and aortic pulse wave velocity (PWV). Moreover, compared with office BP, home BP recordings are stronger predictors of the rate of renal function decline over time and incident end-stage-renal-disease (ESRD) requiring dialysis. Importantly, home BP recordings were shown to carry stronger value relative to office BP in predicting the risk of all-cause and cardiovascular mortality.
The feasibility of performing repeated home BP monitoring over several days, weeks or months offers the ability to accurately assess alterations in BP levels and responses to antihypertensive therapy in the long-term. Consequently, several randomized controlled studies conducted in the general hypertensive population have provided evidence that home BP monitoring is a simple approach to guide the management of hypertension on a monthly basis. In a meta-analysis of 37 randomized controlled trials (incorporating data from 9,446 hypertensive patients), it was shown that compared with clinic BP-based hypertension management, home BP monitoring was associated with a significantly higher reduction in systolic BP \[weighted mean difference (WMD): -2.63 mmHg; 95% Confidence Interval (CI): -4.24, -1.02\] and in diastolic BP (WMD: -1.68 mmHg; 95% CI: -2.58, -0.79). Implementation of home BP monitoring as a tool to guide the management of hypertension was associated with more frequent reductions in the number of prescribed antihypertensive medications \[relative risk (RR): 2.02; 95% CI: 1.32-3.11\] and reduced the risk of therapeutic inertia, defined as unchanged antihypertensive regimen despite the presence of uncontrolled hypertension (RR: 0.82; 95% CI: 0.68-0.99).
In contrast to the accumulated evidence supporting the use of home BP (HBP)-guided management of hypertension in non-CKD populations, the only study to investigate the role of home BP monitoring as a tool to achieve BP targets in patients with CKD was a previous, small, randomized study enrolling 65 ESRD patients on maintenance hemodialysis. In this study the use of home BP monitoring for 6 months produced a significantly higher reduction in interdialytic ambulatory BP compared to conventional managements of hypertension based on routine pre-dialysis BP recordings (mean 24-hour BP at study-end: 135/76 versus 147/79 mmHg, p\<0.05). Despite the fact that the use of home BP monitoring among people with hypertension and CKD is anticipated to overcome the barriers of white coat and masked hypertension effects and improve therapeutic inertia, there is still no solid evidence on the value of using this technique as a simple approach to improve BP control and maximize the associated benefits on regression of target-organ damage.
The feasibility of performing repeated home BP monitoring over several days, weeks or months offers the ability to accurately assess alterations in BP levels and responses to antihypertensive therapy in the long-term. Consequently, several randomized controlled studies conducted in the general hypertensive population have provided evidence that home BP monitoring is a simple approach to guide the management of hypertension on a monthly basis. In a meta-analysis of 37 randomized controlled trials (incorporating data from 9,446 hypertensive patients), it was shown that compared with clinic BP-based hypertension management, home BP monitoring was associated with a significantly higher reduction in systolic BP \[weighted mean difference (WMD): -2.63 mmHg; 95% Confidence Interval (CI): -4.24, -1.02\] and in diastolic BP (WMD: -1.68 mmHg; 95% CI: -2.58, -0.79). Implementation of home BP monitoring as a tool to guide the management of hypertension was associated with more frequent reductions in the number of prescribed antihypertensive medications \[relative risk (RR): 2.02; 95% CI: 1.32-3.11\] and reduced the risk of therapeutic inertia, defined as unchanged antihypertensive regimen despite the presence of uncontrolled hypertension (RR: 0.82; 95% CI: 0.68-0.99).
In contrast to the accumulated evidence supporting the use of home BP (HBP)-guided management of hypertension in non-CKD populations, the only study to investigate the role of home BP monitoring as a tool to achieve BP targets in patients with CKD was a previous, small, randomized study enrolling 65 ESRD patients on maintenance hemodialysis. In this study the use of home BP monitoring for 6 months produced a significantly higher reduction in interdialytic ambulatory BP compared to conventional managements of hypertension based on routine pre-dialysis BP recordings (mean 24-hour BP at study-end: 135/76 versus 147/79 mmHg, p\<0.05). Despite the fact that the use of home BP monitoring among people with hypertension and CKD is anticipated to overcome the barriers of white coat and masked hypertension effects and improve therapeutic inertia, there is still no solid evidence on the value of using this technique as a simple approach to improve BP control and maximize the associated benefits on regression of target-organ damage.
Conditions
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Hypertension
Chronic Kidney Diseases
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Home BP Monitoring Group
Patients allocated to this group will receive a home blood pressure monitoring device and decisions to modify the hypertension treatment will be based on the results of the home blood pressure monitoring in accordance with the current guidelines of the European Society for Hypertension for the Treatment of Hypertension.
Group Type
EXPERIMENTAL
Home Blood Pressure Monitoring
Intervention Type
DIAGNOSTIC_TEST
Patients randomly assigned to the HBP-guided management group will perform home BP monitoring for 7 days with the use of a validated self-inflating automatic oscillometric device (HEM 705 CP, Omron Healthcare). Home BP monitoring will be performed according to the currently available European Society of Hypertension guidelines at the baseline visit and will be repeated 1 week before the prespecified follow-up visits (at Month 1, Month 2 and Month 4). Patients randomly assigned to the control group will receive conventional management of hypertension based on office BP recordings obtained with the same BP monitor (HEM 705 CP, Omron Healthcare) during the same prespecified follow-up visits.
Office BP Monitoring Group
Patients allocated to this group will act as controls. They will receive no home blood pressure monitoring device and decisions to modify the hypertension treatment will be based exclusively on blood pressure measurements in office visits.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Home Blood Pressure Monitoring
Patients randomly assigned to the HBP-guided management group will perform home BP monitoring for 7 days with the use of a validated self-inflating automatic oscillometric device (HEM 705 CP, Omron Healthcare). Home BP monitoring will be performed according to the currently available European Society of Hypertension guidelines at the baseline visit and will be repeated 1 week before the prespecified follow-up visits (at Month 1, Month 2 and Month 4). Patients randomly assigned to the control group will receive conventional management of hypertension based on office BP recordings obtained with the same BP monitor (HEM 705 CP, Omron Healthcare) during the same prespecified follow-up visits.
Intervention Type
DIAGNOSTIC_TEST
Eligibility Criteria
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Inclusion Criteria
* Age 18 years old or higher
* Stable CKD stage 3-4 (CKD-EPI estimated GFR: 15-60 ml/min/1.73m2)
* Treated or untreated uncontrolled hypertension, defined as office BP \>140/90 mmHg for patients with diabetic or non-diabetic CKD and protein excretion \<0.3 gr/day or office BP \>130/80 mmHg for patients with diabetic or non-diabetic CKD and protein excretion ≥0.3 gr/day.22-24
* Patients must provide informed written consent
* Stable CKD stage 3-4 (CKD-EPI estimated GFR: 15-60 ml/min/1.73m2)
* Treated or untreated uncontrolled hypertension, defined as office BP \>140/90 mmHg for patients with diabetic or non-diabetic CKD and protein excretion \<0.3 gr/day or office BP \>130/80 mmHg for patients with diabetic or non-diabetic CKD and protein excretion ≥0.3 gr/day.22-24
* Patients must provide informed written consent
Exclusion Criteria
* End-stage renal disease under hemodialysis or peritoneal dialysis
* Known secondary cause of hypertension (i.e., pheochromocytoma, primary aldosteronism, renovascular hypertension)
* Chronic atrial fibrillation
* Hospitalization for acute myocardial infarction, unstable angina or acute ischemic stroke within the 3 previous months
* Severe congestive heart failure stage III-IV according to New York Heart Association (NYHA) classification
* Body mass index (BMI) of \>40 kg/m2
* History of malignancy or any other clinical condition associated with very poor prognosis
* Known secondary cause of hypertension (i.e., pheochromocytoma, primary aldosteronism, renovascular hypertension)
* Chronic atrial fibrillation
* Hospitalization for acute myocardial infarction, unstable angina or acute ischemic stroke within the 3 previous months
* Severe congestive heart failure stage III-IV according to New York Heart Association (NYHA) classification
* Body mass index (BMI) of \>40 kg/m2
* History of malignancy or any other clinical condition associated with very poor prognosis
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Aristotle University Of Thessaloniki
OTHER
Sponsor Role
lead
Responsible Party
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E. Champidou
Medical Doctor, Internal Medicine Specialist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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AHEPA University Hospital of Thessaloniki
Thessaloniki, Makedonia, Greece
Site Status
RECRUITING
Countries
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Greece
Central Contacts
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Facility Contacts
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Pantelis Zempekakis, Professor
Role: primary
References
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Levin A, Tonelli M, Bonventre J, Coresh J, Donner JA, Fogo AB, Fox CS, Gansevoort RT, Heerspink HJL, Jardine M, Kasiske B, Kottgen A, Kretzler M, Levey AS, Luyckx VA, Mehta R, Moe O, Obrador G, Pannu N, Parikh CR, Perkovic V, Pollock C, Stenvinkel P, Tuttle KR, Wheeler DC, Eckardt KU; ISN Global Kidney Health Summit participants. Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy. Lancet. 2017 Oct 21;390(10105):1888-1917. doi: 10.1016/S0140-6736(17)30788-2. Epub 2017 Apr 20.
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Other Identifiers
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4475
Identifier Type: -
Identifier Source: org_study_id
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The Effect of Home Blood Pressure Measurement on the Management of Hypertension
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ACTIVE_NOT_RECRUITING
A Study in the Use of Home Blood Pressure Monitoring and Telephone Follow-up to Control Blood Pressure
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COMPLETED
PHASE1
Efficacy of Home Blood Pressure Monitoring (MONITOR Study)
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COMPLETED
NA
Implementing a Home Blood Pressure Monitoring Program in Primary Care
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ACTIVE_NOT_RECRUITING
NA
Use of Automated Office Blood Pressure Monitoring
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COMPLETED
NA
24-hour Ambulatory Blood Pressure Monitoring in Patients With Blood Pressure Above Thresholds in General Practice
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UNKNOWN
Registry Study on "Control Nocturnal Hypertension to Reach the Target "
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RECRUITING
Remote Monitoring and Virtual Collaborative Care For Hypertension Control To Prevent Cognitive Decline
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COMPLETED
NA
Management of Uncontrolled Hypertension (HTN)
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TERMINATED
NA
Hypertension Registry of "Hypertension Prevention and Control Initiative in China"
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UNKNOWN
Home Blood Pressure Monitoring and Blood Pressure Control
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COMPLETED
NA