Comparison of Carvedilol and Atorvastatin for Preventing of Contrast-Induced Nephropathy.

NCT03867994 | Completed Phase 2 DMC

• 1 other identifier: beta-blockers and statins
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective study is intended to evaluate if carvedilol has any potential protective effect over atorvastatin on the development of contrast-induced nephropathy (CIN) following cardiac catheterization in patients with moderate to high risk for CIN.

Conditions

Contrast-induced Nephropathy

Keywords

Cardiac catheterization, carvedilol, atorvastatin.

Outcome Measures

Primary Outcomes (1)

• development of contrast induced nephropathy

  CIN :(defined as absolute rise in the baseline serum creatinine concentration by 0.5 mg/dL after 48 hours from CC).

  1. Serum creatinine baseline was measured from venous blood (before initiating the hydration) and 48 hours after the CC procedure.

Secondary Outcomes (1)

• Estimated Glomerular filtration rate (eGFR)

  on admission, and re-calculated 48 hours post CC using

Other Outcomes (2)

• Blood urea nitrogen (BUN)

  On admission, and re-calculated 48 hours post CC using

• Serum Neutrophil gelatinase - associated lipocalin (NGAL) Description: . NGAL was assayed by enzyme -linked immunosorbent assay ELISA (Glory Science Co., Ltd, CHINA).

  Baseline was measured from venous blood before the initiation of hydration, and 4 hours after CC procedure.

Study Arms (3)

Group (A)

EXPERIMENTAL

included 49 patients who received high dose statin (80 mg atorvastatin) 12 hours before CC and 40 mg just before CC +hydration with saline (0.9% NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization.

Drug: Atorvastatin; Drug: saline

Group (B)

EXPERIMENTAL

included 48 patients who received 12.5 mg carvedilol twice daily for 7 days before CC and continued for 24 hours after the CC +hydration with saline (0.9% NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization.

Drug: Carvedilol; Drug: saline

Group (C)

EXPERIMENTAL

included 47 patients who did not receive any medications but only hydration with saline (0.9% NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization

Drug: saline

Interventions

Atorvastatin DRUG

Group (A)

Carvedilol DRUG

Group (B)

saline DRUG

Also known as: 0.9%NaCl

Group (A); Group (B); Group (C)

Eligibility Criteria

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

You may qualify if:

• Patients aged between 18 and 70 years.
• Serum creatinine ≤ 1.5 mg/dL.
• Using a moderate dose of atorvastatin (40 mg or equivalent dose of other statins).
• Moderate to high-risk for CIN.

You may not qualify if:

• Patients suffering from ST-segment elevation myocardial infarction (STEMI)
• Patients need for immediate cardiac catheterization
• Elevated liver enzymes (Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) three times the upper limit of normal).
• Active infection.
• Any contraindication to carvedilol, or atorvastatin.
• Patients on regular use of vitamins, minerals.
• Using medication with antioxidant properties e.g., beta-carotene, vitamin E, vitamin C, selenium, theophylline or N-acetyl cysteine 7 days prior to CC.
• Hemodynamically unstable patients (defined as abnormal or unstable blood pressure, especially hypotension (blood pressure less than 90/60 mm Hg).
• Patients who required dialysis.
• Pregnancy.
• Using of carvedilol in the past three months.
• Using a nephrotoxic agent in the past 48 hours or exposure to a contrast agent in the past 7 days prior to cardiac catheterization.

Sponsors & Collaborators

• rabab ahmed mohamed: lead
• Cairo University: collaborator

MeSH Terms

Interventions

Atorvastatin; Carvedilol; Sodium Chloride

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the patients were selected randomly and divided for three groups prospectively. the design was single-blinded randomized controlled study at which the researcher was aware by the allocation of the groups while the patients were blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Teaching Assistant in clinical pharmacy department

Model Details: This prospective study is intended to evaluate if carvedilol has any potential protective effect over atorvastatin on the development of contrast-induced nephropathy (CIN) following cardiac catheterization in patients with moderate to high risk for CIN.

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: March 8, 2019
• Study Start: February 1, 2016
• Primary Completion: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: March 12, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be available from the time of publication