ACEi ARB Withdrawal in CKD Patients

Study Overview
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Brief Summary
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The American Heart Association guidelines for high blood pressure (BP) currently recommend using angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs) as first-line therapy for patients with chronic kidney disease (CKD) stage 3 or above. However, the prevalence of ACEi and ARB use in patients with CKD stage 4 or 5 is low, and current BP guidelines acknowledge the lack of solid evidence to support the benefit of using these agents in advanced CKD.This study seeks to conduct a pilot trial to determine the safety and feasibility of ACEi and/or ARB continuation (intervention) versus withdrawal (control) in patients with advanced CKD.

Official Title
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Angiotensin-converting Enzyme Inhibitors (ACEi) or Angiotensin Receptor Blockers (ARB) Withdrawal in Patients With Advanced Chronic Kidney Disease

Conditions
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Chronic Kidney Disease, Blood Pressure, Angiotensin-converting Enzyme Inhibitor, Angiotensin Receptor Blockers

Intervention / Treatment
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* Other: Continuation of ACEi and/or ARBs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults ≥18 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 < 25 mL/min/1.73m2 or prior diagnosis of CKD (per electronic chart review) and at least one eGFR < 25 mL/min/1.73m2 in the past six months receiving at least one antihypertensive medication at the time of the screening visit. Exclusion Criteria: The investigators will exclude 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 cognitive impairment prohibiting participation in the study on dialysis at time of recruitment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACEi/ARB continuation<br>Intervention group will continue or start to take ACEi and/or ARBs | Other: Continuation of ACEi and/or ARBs<br>* Patients will continue or start taking ACEi and/or ARBs<br>|
| No Intervention: ACEi/ARB withdrawal<br>The control group will discontinue ACEi and/or ARBs which may be substituted with other anti-hypertensive agents (if already taking ACEi/ARB) or continue to not take ACEi/ARBs | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of enrollment and dropout in trial | measure of acceptability of continuing ACEi/ARBs among providers and patients | Months 1-12 | 
| Number of patients who have onset of hyperkalemia (non-hemolyzed potassium ≥6.0 meq/L) | safety measure | Months 1-12 | 
| Number of all cause emergency room visits | safety measure | Months 1-12 | 
| Number of all-cause hospitalizations | safety measure | Months 1-12 | 
| Number of falls and syncope reported by patients and/or discharge summaries | safety measure | Months 1-12 | 
| Number of patients who receive chronic dialysis or kidney transplant | Marks the onset of end-stage renal disease | Months 1-12 |