Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments standard saline infusion, fenoldopam infusion
Phase phase 4
Sponsor University of Roma La Sapienza
Start date September 2012
End date December 2013
Trial size 100 participants
Trial identifier NCT01690832, 595/2012/D

Summary

Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury (AKI) when they undergo urgent/emergency coronary angiography.

The optimal medical treatment for preventing the occurrence of contrast induced - acute kidney injury is still controversial.

Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary studies.

Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy.

The primary objective of this study is to to test the hypothesis that fenoldopam, in addition to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography and/or percutaneous coronary intervention.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
standard i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure.
standard saline infusion saline infusion
i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure
(Active Comparator)
combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure.
standard saline infusion saline infusion
i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure
fenoldopam infusion fenoldopam administration (0.08 mcg/Kg/min)
combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure

Primary Outcomes

Measure
Contrast induced acute kidney injury
time frame: 48 hour

Secondary Outcomes

Measure
Markers of kidney injury
time frame: 48 hour

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Indication to urgent/emergency coronary angiography - Normal renal function (eGFR> 60 ml/min/1.73 m2) - Moderate or high Mehran's risk score for CIN (>11). - Able to understand and willing to sign the informed CF Exclusion Criteria: • Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

Additional Information

Official title Fenoldopam for Prevention of Acute kidNey Injury in Patients With aCute coronarY Syndrome Undergoing Coronary Angiography and/or Percutaneous Coronary Intervention - The FANCY Trial
Principal investigator Francesco Pelliccia, MD
Description Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury (AKI) when they undergo urgent/emergency coronary angiography. The optimal medical treatment for preventing the occurrence of contrast induced - acute kidney injury is still controversial. Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary studies. Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy. The primary objective of this study is to to test the hypothesis that fenoldopam, in addition to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography and/or percutaneous coronary intervention. Patients will be randomized to standard i.v. 1 ml/kg/h saline infusion (Gr. A, N= 50) or to a combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure. Primary End-points • Incidence of contrast induced acute kidney injury Secondary End-points • Post-angiographic 48-h absolute increase in creatinine, absolute increase in estimated glomerular filtration rate, and Neutrophil gelatinase-associated lipocalin (NGAL) value
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by University of Roma La Sapienza.