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

Hypertension Clinical Trial

— PERFORMANCE  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02975505
• Other study ID #: 16-20978
• Status: Suspended
• Phase: N/A
• Start date: February 10, 2017
• Est. completion date: July 2026

Study information

• Verified date: July 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bloodpressure
• Chronic Kidney Disease
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Strict blood pressure control
Systolic Blood Pressure Target < 120 mm Hg (measured at home)

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyperkalemia	Hyperkalemia: This will be defined as a non-hemolyzed potassium =6.0 meq/L.	Months 1-12 and study end
Primary	Achieved Blood Pressure		Months 4-12 and study end
Primary	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.	Months 1-12 and study end
Primary	End-stage Renal Disease	Defined as receipt of chronic dialysis or kidney transplant	Month 1 to study end
Secondary	Number of participants screened who enroll in trial	Feasibility of enrollment	Months 0-12