Continuing or Discontinuing ACE/ARBs in Patients With Chronic Kidney Disease Undergoing Coronary Angiography

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Continuing or Discontinuing ACE-I/ARBs Therapy on the Incidence of Contrast-induced Nephropathy in Patients With Chronic Kidney Disease Undergoing Coronary Angiography; a Randomized Controlled Trial

Conditions
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Contrast-induced Nephropathy, Chronic Kidney Diseases, Ischemic Heart Disease

Intervention / Treatment
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* Other: Continue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan )
* Other: Hold ACEI or ARBs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continue ACEI or ARBs<br>Randomized to continue on prescribed ACE1 or ARBs | Other: Continue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan )<br>* Randomized to continue on prescribed ACE1 or ARBs ( Enalapril 5, 10, 20 mg // Ramipril 2.5 , 5 mg // Valsartan 80 , 160 mg // Candesartan 8, 16 mg // Losartan 50 mg )<br>* Other names: Continue ACEI or ARBs;|
| Active Comparator: Hold ACEI or ARBs<br>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) | Other: Hold ACEI or ARBs<br>* Angiotensin converting enzyme inhibitor or angiotensin receptor blocker held at least 24 hours pre-cardiac catheterization and restarted 48-72 hours post-catheterization (after creatinine measurement) Other Name: Includes all ACEI inhibitors or ARBs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Contrast induced nephropathy | 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 | 48 - 72 hours post-cardiac catheterization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine level | Change in serum creatinine at 48-72hrs | 48 - 72 hours post-cardiac catheterization | 
| Number of Participants with Hyperkalemia | Serum potassium increased to > 5.5 mg/dL at 48-72hrs | 48 - 72 hours post-cardiac catheterization | 
| Creatinine clearance | Change in Creatinine clearance 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 | Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-72hrs | 48 - 72 hours post-cardiac catheterization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac catherization, coronary angiography, Coronary angioplasty, chronic kidney disease, contrast induced nephropathy, ACEI, ARBs