Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology
Healthy:No
Age Range:16 - Any
Updated:9/30/2018
Start Date:February 10, 2017
End Date:July 2019
Contact:Elaine Ku, MD
Email:Elaine.Ku@ucsf.edu
Phone:415-353-2507

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The transition from chronic kidney disease (CKD) to end-stage renal disease ESRD is a
vulnerable and challenging period of time for patients and providers. Suboptimal control of
blood pressure is known to be common in patients with the advanced stages of CKD, and may
contribute to their elevated risk of progression to ESRD, cardiovascular morbidity, and
mortality. This proposal is a pilot randomized controlled trial designed to test whether
intensive blood pressure lowering is feasible and safe in patients with advanced CKD as they
transition to ESRD.

The transition from advanced chronic kidney disease (CKD), when estimated glomerular
filtration rate (eGFR) is <30 mL/min/1.73m2, to end-stage renal disease (ESRD) represents a
vulnerable period, when multiple physiologic and psychosocial changes occur as patients
prepare for either dialysis or kidney transplant. This study is a pilot randomized controlled
trial to test the safety and feasibility of studying strict versus usual BP control in a
population of patients with advanced CKD (eGFR <30 mL/min/1.73m2), including those with
diabetes. For this pilot study, we will randomize 60 patients with advanced CKD who have
elevated BP to either a home SBP target of <120 mm Hg (intervention group) versus 130-140 mm
Hg (usual care group).

Inclusion Criteria:

Adults ≥16 years of age who meet the eGFR eligibility criteria, which will be determined
based on whether participants have

1. at least two eGFR in the last three months that are <30 mL/min/1.73m2 or

2. prior diagnosis of CKD (per electronic chart review) and at least one eGFR <30
mL/min/1.73m2

3. history of hypertension

4. mid-arm circumference between 22-37cm (BP cuff size limitation) and be able to provide
consent to participate in our study.

Exclusion criteria

Those who:

- are or are planning to become pregnant, due to inability to take multiple classes of
anti-hypertensive agents

- are marginally housed, due to concerns regarding routine follow-up

- are actively participating in a different interventional trial that may affect blood
pressure

- are unwilling to consent to participate

- institutionalized individuals or prisoners

- are actively abusing illicit drugs or alcohol

- have a history of poor or doubtful compliance (e.g., frequently missed appointments)

- have office SBP >170 mmHg

- are already taking ≥5 anti-hypertensive medications (any classes, including diuretics)
have cognitive impairment prohibiting participation in the study.
We found this trial at
1
site
San Francisco, California 94143
Phone: 562-405-4199
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San Francisco, CA
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