Clinical trial NCT02975505: Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD
Official title: Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Kidney Disease
Bloodpressure
Hypertension
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 108
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Achieved Clinic Systolic Blood Pressure
timeFrame: At month 12
measure: Difference in Clinic SBP Between the Two Arms
timeFrame: Months 4-12
measure: Hyperkalemia, Syncope, Falls, ESKD
timeFrame: Months 0-12
Secondary outcomes:
measure: Screening to Enrollment Ratio
timeFrame: From baseline entry through the end of Year 3 of study
Other outcomes:
measure: Difference in Achieved SBP
timeFrame: Between month 4 after baseline and year 4 of study
measure: Hyperkalemia, Syncope, Falls, ESKD
timeFrame: Between month 4 after baseline and year 4 of study
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Raymond Hsu, MD MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Elaine Ku, MD MAS
role: PRINCIPAL_INVESTIGATOR
References: