ACEi ARB Withdrawal in CKD Patients

University of California San Francisco (UCSF)

Status: Withdrawn

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

Treatments: Other: Continuation of ACEi and/or ARBs

Study type: Interventional

Funder types: Other

Identifiers

NCT03957161

18-25554

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

ACEi/ARB continuation

Experimental group

Description:

Intervention group will continue or start to take ACEi and/or ARBs

Treatment:

Other: Continuation of ACEi and/or ARBs

ACEi/ARB withdrawal

No Intervention group

Description:

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