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

Not Applicable

Suspended

• Conditions: Hypertension; Bloodpressure; Chronic Kidney Disease
• Interventions: Other: Strict blood pressure control

• Registration Number: NCT02975505
• Lead Sponsor: University of California, San Francisco

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 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 130-140 mm Hg (usual care group).

Study Timeline

• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-29
• Study Start: 2017-02-10
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-01
• Last Update Posted: 2022-07-06
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 200

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Secondary Outcome Measures

Name	Time	Method
Number of participants screened who enroll in trial	Months 0-12	Feasibility of enrollment

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States