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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 120 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).

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

Conditions
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Chronic Kidney Disease, Bloodpressure, Hypertension

Intervention / Treatment
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* Other: Strict blood pressure control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥16 years of age who meet the eGFR eligibility criteria, which will be determined based on whether participants have at least two eGFR in the last three months that are <=30 mL/min/1.73m2 or prior diagnosis of CKD (per electronic chart review) and at least one eGFR <=30 mL/min/1.73m2 history of hypertension 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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strict SBP Target<br>Target Systolic Blood Pressure <120 mm Hg | Other: Strict blood pressure control<br>* Systolic Blood Pressure Target < 120 mm Hg (measured at home)<br>|
| No Intervention: Usual SBP Target<br>Target Systolic Blood Pressure 130-140 mm Hg | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperkalemia | Hyperkalemia: This will be defined as a non-hemolyzed potassium ≥6.0 meq/L. | Months 1-12 and study end | 
| Achieved Blood Pressure |  | Months 4-12 and study end | 
| Falls and syncope by self-report or based on emergency room visits | Falls and syncope: This will be defined based on self-report or if either is the chief complaint for an ER visit. | Months 1-12 and study end | 
| End-stage Renal Disease | Defined as receipt of chronic dialysis or kidney transplant | Month 1 to study end | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants screened who enroll in trial | Feasibility of enrollment | Months 0-12 |