Angiotensin-converting Enzyme Inhibitor, Angiotensin Receptor Blockers, Blood Pressure, Chronic Kidney Disease
Conditions
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.
Interventions
OTHERContinuation of ACEi and/or ARBs
Patients will continue or start taking ACEi and/or ARBs
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of enrollment and dropout in trial | Months 1-12 | measure of acceptability of continuing ACEi/ARBs among providers and patients |
| Number of patients who have onset of hyperkalemia (non-hemolyzed potassium ≥6.0 meq/L) | Months 1-12 | safety measure |
| Number of all cause emergency room visits | Months 1-12 | safety measure |
| Number of all-cause hospitalizations | Months 1-12 | safety measure |
| Number of falls and syncope reported by patients and/or discharge summaries | Months 1-12 | safety measure |
| Number of patients who receive chronic dialysis or kidney transplant | Months 1-12 | Marks the onset of end-stage renal disease |
Countries
United States
Outcome results
None listed