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

University of California San Francisco (UCSF)

Status: Terminated

Conditions: Chronic Kidney Disease; Hypertension; Bloodpressure

Treatments: Other: Strict blood pressure control

Study type: Interventional

Funder types: Other

Identifiers

NCT02975505

16-20978

Details and patient eligibility

About

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.

Full 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).

Enrollment: 108 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups

Strict SBP Target

Experimental group

Description:

Target Systolic Home Blood Pressure \<120 mm Hg

Treatment:

Other: Strict blood pressure control

Usual SBP Target

No Intervention group

Description:

Target Systolic Home Blood Pressure 130-140 mm Hg