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

Primary Purpose

Chronic Kidney Disease, Bloodpressure, Hypertension

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strict blood pressure control
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Strict SBP Target

Usual SBP Target

Arm Description

Target Systolic Blood Pressure <120 mm Hg

Target Systolic Blood Pressure 130-140 mm Hg

Outcomes

Primary Outcome Measures

Hyperkalemia
Hyperkalemia: This will be defined as a non-hemolyzed potassium ≥6.0 meq/L.
Achieved Blood Pressure
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.
End-stage Renal Disease
Defined as receipt of chronic dialysis or kidney transplant

Secondary Outcome Measures

Number of participants screened who enroll in trial
Feasibility of enrollment

Full Information

First Posted
November 22, 2016
Last Updated
July 1, 2022
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02975505
Brief Title
Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD
Acronym
PERFORMANCE
Official Title
Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Suspended
Why Stopped
Due to challenges in recruitment and holding visits during COVID
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Bloodpressure, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Strict SBP Target
Arm Type
Experimental
Arm Description
Target Systolic Blood Pressure <120 mm Hg
Arm Title
Usual SBP Target
Arm Type
No Intervention
Arm Description
Target Systolic Blood Pressure 130-140 mm Hg
Intervention Type
Other
Intervention Name(s)
Strict blood pressure control
Intervention Description
Systolic Blood Pressure Target < 120 mm Hg (measured at home)
Primary Outcome Measure Information:
Title
Hyperkalemia
Description
Hyperkalemia: This will be defined as a non-hemolyzed potassium ≥6.0 meq/L.
Time Frame
Months 1-12 and study end
Title
Achieved Blood Pressure
Time Frame
Months 4-12 and study end
Title
Falls and syncope by self-report or based on emergency room visits
Description
Falls and syncope: This will be defined based on self-report or if either is the chief complaint for an ER visit.
Time Frame
Months 1-12 and study end
Title
End-stage Renal Disease
Description
Defined as receipt of chronic dialysis or kidney transplant
Time Frame
Month 1 to study end
Secondary Outcome Measure Information:
Title
Number of participants screened who enroll in trial
Description
Feasibility of enrollment
Time Frame
Months 0-12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Hsu, MD MAS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elaine Ku, MD MAS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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