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

NCT05271448 | Unknown DMC

• 1 other identifier: ACEI/ARBs/CKD/CATH
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Serum creatinine level

  48 - 72 hours post-cardiac catheterization

• Number of Participants with Hyperkalemia

  48 - 72 hours post-cardiac catheterization

• Creatinine clearance

  48 - 72 hours post-cardiac catheterization

• Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-72hrs

  48 - 72 hours post-cardiac catheterization

Study Arms (2)

Continue ACEI or ARBs

EXPERIMENTAL

Randomized to continue on prescribed ACE1 or ARBs

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

Hold ACEI or ARBs

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Continue ACEI or ARBs

Continue ACEI or ARBs

Hold ACEI or ARBs 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

Hold ACEI or ARBs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• An-Najah National University: lead

Study Sites (1)

An-Najah National University Hospital

Nablus, West Bank, P4170051, Palestinian Territories

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Myocardial Ischemia

Interventions

Enalapril; Ramipril; Valsartan; candesartan; Losartan

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Essential; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles

Study Officials

• Yunis A Daralammouri, asst. prof.

  An-Najah National University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunis A Daralammouri, asst. prof.

CONTACT

+970598434614; yunis71@yahoo.de

Murad M Azamtta, MD

CONTACT

+972595762566; m.azamttah@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 15, 2022
• First Posted: March 9, 2022
• Study Start: June 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

PA (1)