Continuing or Discontinuing ACE/ARBs in Patients With Chronic Kidney Disease Undergoing Coronary Angiography
- Conditions
- Chronic Kidney DiseasesIschemic Heart DiseaseContrast-induced Nephropathy
- Interventions
- Other: Continue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan )Other: Hold ACEI or ARBs
- Registration Number
- NCT05271448
- Lead Sponsor
- An-Najah National University
- Brief Summary
Contrast induced nephropathy (CIN) is a well-known possible complication of percutaneous coronary intervention (PCI) with an incidence varies from 3.3% to 14.5% in patients undergoing PCI.
Many previous randomized and non-randomized studies have shown very conflicting results regarding the use of ACE-Is prior to coronary angiography, and whether it decreases or increases the risk of CIN. The importance of this study is to help find an acceptable and reliable answer for the use of ACE-I/ARBs prior to cardiac catheterization.
This research aims to study the effect of withholding ACE-Is or ARBs on the incidence of contrast induced nephropathy in patients undergoing coronary angiography who have chronic kidney disease (GFR\<60 ml/min/1.73 m2) and to help build evidence-based data and guidelines on the safety of continuing or withholding ACE-I/ARBs pre contrast administration.
- Detailed Description
The study design is a Randomized Control Trial; it will be done on two groups of patients. The two groups are group A (continue ACE-I/ARBs) and group B (withhold ACE-I/ARBs).
The study will be conducted at the cardiology units at An-Najah National University's hospital (NNUH) in Nablus, Palestine.
Study population includes chronic kidney disease patients taking ACE-I or ARBs therapy and are undergoing elective coronary angiography.
Patients who will meet the inclusion criteria and have none of the exclusion criteria will be enrolled in the trial when the appointment of their procedure is set.
They will be randomly divided into two groups; group A (continue ACE-I or ARBs therapy) and group B (withhold ACE-I or ARBs therapy)using block randomization, each block consists of four participants.
Patients in the continuation group will take their regular ACE-I/ARBs on the day of the angiogram. Patients in the discontinuation group will be withheld from their ACEI or ARBs 24 h before cardiac catheterization.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- At least one month of continuous therapy with an ACEI or an ARBs and
- Undergoing elective coronary angiography and
- Have CKD stage3-4 (15≤GFR<60 ml/min/1.73 m2).
- Acute STEMI within 2 weeks
- NYHA class IV heart failure by history
- Administration of contrast load within the previous 6 days
- acute renal failure (ARF) preceding coronary angiography
- potassium level more than 5.0 meq/l
- GFR <15 ml/min/1.73 m2
- previous percutaneous cardiac catheterization within one month
- Acute pulmonary edema
- hemodynamically instability
- uncontrolled hypertension
- combination ACEI and ARB therapy
- Cardiogenic shock
- Sepsis
- pregnancy
- Age below 18 year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continue ACEI or ARBs Continue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan ) Randomized to continue on prescribed ACE1 or ARBs Hold ACEI or ARBs Hold ACEI or ARBs Angiotensin converting enzyme inhibitor or angiotensin receptor blocker held \>= 24 hours pre-cardiac catheterization and restarted post-catheterization after creatinine measurement (48-72 hours post)
- Primary Outcome Measures
Name Time Method Number of Participants with Contrast induced nephropathy 48 - 72 hours post-cardiac catheterization Contrast induced nephropathy (creatinine rise of ≥0.5 mg/dL or a relative increase ≥25%compared to the pre-randomization creatinine level) at 48-72hrs
- Secondary Outcome Measures
Name Time Method Serum creatinine level 48 - 72 hours post-cardiac catheterization Change in serum creatinine at 48-72hrs
Creatinine clearance 48 - 72 hours post-cardiac catheterization Change in Creatinine clearance at 48-72hrs
Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-72hrs 48 - 72 hours post-cardiac catheterization Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-72hrs
Number of Participants with Hyperkalemia 48 - 72 hours post-cardiac catheterization Serum potassium increased to \> 5.5 mg/dL at 48-72hrs
Trial Locations
- Locations (1)
An-Najah National University Hospital
🇵🇸Nablus, West Bank, Palestinian Territory, occupied