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

Not Applicable

Terminated

Brief Summary: 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 home blood pressure lowering is feasible and safe in patients with advanced CKD as they transition to ESRD.

Detailed Description: 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 usual care (130-140 mmHg).

Recruitment & Eligibility

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.

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Strict SBP Target	Strict blood pressure control	Target Systolic Blood Pressure \<120 mm Hg

Primary Outcome Measures

Name	Time	Method
Achieved Clinic Systolic Blood Pressure	At month 12	Achieved clinic SBP at month 12
Difference in Clinic SBP Between the Two Arms	Months 4-12	Incorporating achieved mean SBP data between months 4-12
Hyperkalemia, Syncope, Falls, ESKD	Months 0-12	Potassium \>=6 or self-reported syncope or falls or discharge diagnosis of acute kidney injury from emergency room or hospitalization

Secondary Outcome Measures

Name	Time	Method
Screening to Enrollment Ratio	From baseline entry through the end of Year 3 of study	This is the number of potential participants screened as eligible to the number who agree to enroll