Angiotensin-converting Enzyme Inhibitors (ACEi) or Angiotensin Receptor Blockers (ARB) Withdrawal in Patients With Advanced Chronic Kidney Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Number of patients who have onset of hyperkalemia (non-hemolyzed potassium ≥6.0 meq/L)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ACEi/ARB continuation
Intervention group will continue or start to take ACEi and/or ARBs
Intervention: Continuation of ACEi and/or ARBs (Other)
ACEi/ARB withdrawal
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
Outcomes
Primary Outcomes
Number of patients who have onset of hyperkalemia (non-hemolyzed potassium ≥6.0 meq/L)
Time Frame: Months 1-12
safety measure
Number of all cause emergency room visits
Time Frame: Months 1-12
safety measure
Number of falls and syncope reported by patients and/or discharge summaries
Time Frame: Months 1-12
safety measure
Number of patients who receive chronic dialysis or kidney transplant
Time Frame: Months 1-12
Marks the onset of end-stage renal disease
Number of all-cause hospitalizations
Time Frame: Months 1-12
safety measure
Rate of enrollment and dropout in trial
Time Frame: Months 1-12
measure of acceptability of continuing ACEi/ARBs among providers and patients
Secondary Outcomes
No secondary outcomes reported