Clinical trial NCT05271448: Continuing or Discontinuing ACE/ARBs in Patients With Chronic Kidney Disease Undergoing Coronary Angiography
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contrast-induced Nephropathy
Chronic Kidney Diseases
Ischemic Heart Disease
Keywords: Cardiac catherization
coronary angiography
Coronary angioplasty
chronic kidney disease
contrast induced nephropathy
ACEI
ARBs
Lead sponsor: An-Najah National University
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of Participants with Contrast induced nephropathy
timeFrame: 48 - 72 hours post-cardiac catheterization
Secondary outcomes:
measure: Serum creatinine level
timeFrame: 48 - 72 hours post-cardiac catheterization
measure: Number of Participants with Hyperkalemia
timeFrame: 48 - 72 hours post-cardiac catheterization
measure: Creatinine clearance
timeFrame: 48 - 72 hours post-cardiac catheterization
measure: Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-72hrs
timeFrame: 48 - 72 hours post-cardiac catheterization
Other outcomes:
Locations:
city: Nablus
country: Palestinian Territory, occupied
facility: An-Najah National University Hospital
state: West Bank
Study officials:
affiliation: An-Najah National University
name: Yunis A Daralammouri, asst. prof.
role: PRINCIPAL_INVESTIGATOR
References: