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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases; Ischemic Heart Disease; Contrast-induced Nephropathy
• Intervention / Treatment: Other: Continue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan ); Other: Hold ACEI or ARBs

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 Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yunis A Daralammouri, asst. prof.; Phone Number: +970598434614; Email: yunis71@yahoo.de
• Study Contact Backup: Name: Murad M Azamtta, MD; Phone Number: +972595762566; Email: m.azamttah@gmail.com

Study Locations

• Palestinian Territory, occupied
  • West Bank
    • Nablus, West Bank, Palestinian Territory, occupied, P4170051
      • Recruiting
      • An-Najah National University Hospital
      • Contact: Murad M Azamtta, MD; Phone Number: +972595762566; Email: m.azamttah@gmail.com
      • Contact: Yunis A Daralammouri, asst. prof; Phone Number: +972598434614; Email: yunis71@yahoo.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. At least one month of continuous therapy with an ACEI or an ARBs and
2. Undergoing elective coronary angiography and
3. Have CKD stage3-4 (15≤GFR<60 ml/min/1.73 m2).

Exclusion Criteria:

1. Acute STEMI within 2 weeks
2. NYHA class IV heart failure by history
3. Administration of contrast load within the previous 6 days
4. acute renal failure (ARF) preceding coronary angiography
5. potassium level more than 5.0 meq/l
6. GFR <15 ml/min/1.73 m2
7. previous percutaneous cardiac catheterization within one month
8. Acute pulmonary edema
9. hemodynamically instability
10. uncontrolled hypertension
11. combination ACEI and ARB therapy
12. Cardiogenic shock
13. Sepsis
14. pregnancy
15. Age below 18 year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: An-Najah National University
• Investigators: Principal Investigator: Yunis A Daralammouri, asst. prof., An-Najah National University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 15, 2022
• First Submitted That Met QC Criteria: February 27, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 4, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: chronic kidney disease; contrast induced nephropathy; coronary angiography; Coronary angioplasty; ACEI; ARBs; Cardiac catherization
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Coronary Disease; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Kidney Diseases; Renal Insufficiency, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan; Enalapril; Losartan; Candesartan; Ramipril; Candesartan cilexetil; Angiotensin-Converting Enzyme Inhibitors
• Other Study ID Numbers: ACEI/ARBs/CKD/CATH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No