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

Sponsor

An-Najah National University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05271448

Collaborator

(none)

600

Enrollment

Location

Arms

Anticipated Duration (Months)

42.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contrast-induced Nephropathy Chronic Kidney Diseases Ischemic Heart Disease	Other: Continue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan ) Other: Hold ACEI or ARBs	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Patients enrolled to the study were randomized into continuing or discontinuing (ACEI/ARBs) group. Care providers and investigators collected their data before and after the coronary angiography. The independent variable - continuing or discontinuing (ACEI/ARBs) - was coded into A or B groups, then data was sent to the outcomes assessor.

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Continue ACEI or ARBs Randomized to continue on prescribed ACE1 or ARBs	Other: Continue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan ) 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 ) Other Names: Continue ACEI or ARBs
Active Comparator: 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)	Other: Hold ACEI or ARBs 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

Arm

Intervention/Treatment

Experimental: Continue ACEI or ARBs

Randomized to continue on prescribed ACE1 or ARBs

Other: Continue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan )

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 )

Other Names:

Continue ACEI or ARBs

Active Comparator: 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)

Other: Hold ACEI or ARBs

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

Outcome Measures

Primary Outcome Measures

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

Serum creatinine level [48 - 72 hours post-cardiac catheterization]
Change in serum creatinine 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
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