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

Chronic Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05271448
• Other study ID #: ACEI/ARBs/CKD/CATH
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2023
• Source: An-Najah National University
• Contact: Yunis A Daralammouri, asst. prof.
• Phone: +970598434614
• Email: yunis71[@]yahoo.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Contrast-induced Nephropathy
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Kidney Diseases
• Myocardial Ischemia
• Renal Insufficiency, Chronic

Intervention

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 )
• 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

Locations

Country	Name	City	State
Palestinian Territory, occupied	An-Najah National University Hospital	Nablus	West Bank

Sponsors (1)

Lead Sponsor	Collaborator
An-Najah National University

Country where clinical trial is conducted

Palestinian Territory, occupied, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum creatinine level	Change in serum creatinine at 48-72hrs	48 - 72 hours post-cardiac catheterization
Secondary	Number of Participants with Hyperkalemia	Serum potassium increased to > 5.5 mg/dL at 48-72hrs	48 - 72 hours post-cardiac catheterization
Secondary	Creatinine clearance	Change in Creatinine clearance at 48-72hrs	48 - 72 hours post-cardiac catheterization
Secondary	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