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

NCT ID: NCT05271448

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2024-08-01

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.

Conditions

Contrast-induced Nephropathy; Chronic Kidney Diseases; Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Continue ACEI or ARBs

Randomized to continue on prescribed ACE1 or ARBs

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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 \>= 24 hours pre-cardiac catheterization and restarted post-catheterization after creatinine measurement (48-72 hours post)

Group Type: ACTIVE_COMPARATOR

Hold ACEI or ARBs

Intervention Type: OTHER

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

Interventions

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 )

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

Continue ACEI or ARBs

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

An-Najah National University

OTHER

Sponsor Role: lead

Responsible Party

Yunis Daralammouri

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yunis A Daralammouri, asst. prof.

Role: PRINCIPAL_INVESTIGATOR

An-Najah National University

Locations

An-Najah National University Hospital

Nablus, West Bank, Palestinian Territories

Site Status: RECRUITING

Countries

Palestinian Territories

Central Contacts

Yunis A Daralammouri, asst. prof.

Role: CONTACT

yunis71@yahoo.de

+970598434614

Murad M Azamtta, MD

Role: CONTACT

m.azamttah@gmail.com

+972595762566

Facility Contacts

Yunis A Daralammouri, asst. prof

Role: primary

yunis71@yahoo.de

+972598434614

Murad M Azamtta, MD

Role: backup

m.azamttah@gmail.com

+972595762566

Other Identifiers

ACEI/ARBs/CKD/CATH

Identifier Type: -

Identifier Source: org_study_id