Home Blood Pressure (HBP)-Guided Management of Hypertension in Stage 3-4 CKD

Summary

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.

Conditions

• Hypertension
• Chronic Kidney Diseases

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-02

Primary Completion

2022-06-30

Completion

2022-09-30

Countries

• Greece

Study Locations