Effect of ACE/ARBs on Kidney Health During Heart Procedures
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
NA · An-Najah National University · NCT05271448
This study is testing whether stopping or continuing heart medications called ACE inhibitors or ARBs affects kidney health in patients with chronic kidney disease during heart procedures.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | An-Najah National University (other) |
| Locations | 1 site (Nablus, West Bank) |
| Trial ID | NCT05271448 on ClinicalTrials.gov |
What this trial studies
This research investigates whether continuing or withholding ACE inhibitors (ACE-I) or angiotensin receptor blockers (ARBs) affects the risk of contrast-induced nephropathy (CIN) in patients with chronic kidney disease undergoing coronary angiography. The study involves a randomized control trial design with two groups: one group continues their ACE-I/ARB therapy, while the other group has their therapy withheld 24 hours prior to the procedure. The aim is to provide evidence-based guidelines on the safety of these medications in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates include patients with chronic kidney disease (GFR between 15 and 60 ml/min/1.73 m2) who have been on ACE-I or ARB therapy for at least one month and are scheduled for elective coronary angiography.
Not a fit: Patients with acute kidney failure, severe heart conditions, or those who have recently undergone similar procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with chronic kidney disease undergoing heart procedures, potentially reducing the incidence of contrast-induced nephropathy.
How similar studies have performed: Previous studies have shown conflicting results regarding the use of ACE-I/ARBs in this context, making this research both relevant and necessary to clarify their role.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nablus, West Bank
- An-Najah National University Hospital — Nablus, West Bank, Palestinian Territory, occupied (RECRUITING)
Study contacts
- Principal investigator: Yunis A Daralammouri, asst. prof. — An-Najah National University
- Study coordinator: Yunis A Daralammouri, asst. prof.
- Email: yunis71@yahoo.de
- Phone: +970598434614
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Contrast-induced Nephropathy, Chronic Kidney Diseases, Ischemic Heart Disease, Cardiac catherization, coronary angiography, Coronary angioplasty, chronic kidney disease, contrast induced nephropathy