Renal Effects of Intrarenal Nesiritide

• Status: Terminated
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The impact of nesiritide in CHF is unclear, but it is possible that systemic vasodilation leads to adverse consequences even if the direct renal effects are positive. Therefore, this study will look at the effects of direct intrarenal administration of nesiritide on GFR and RPF.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Treatments: Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

• Hospitalized for worsening CHF and volume overload

• Creatinine increased by greater than or equal to 0.2 and greater than or equal to 10% above baseline at study initiation

• Age greater than or equal to 18 years

• NHYA class II-IV at the time of initiation in the study

• EF less than or equal to 40%

• Signed Informed Consent

Exclusion Criteria:

• Current or anticipated need for dialysis during the study period

• Systolic blood pressure less than or equal to 90 mmHg

• Calculated CrCL based on Cockcroft-Gault less than or equal to 15 cc/min

• Hypersensitivity to nesiritide

• Cardiogenic shock

• Clinically significant aortic or mitral stenosis

• Contraindication to vasodilator treatment

• Inability to withstand 11-15 hours without diuretics

• Suspected renal deterioration due to causes unrelated to CHF such as radiocontrast administration, NSAID use

• Receipt of dose of NSAID within 12 hours of study drug initiation

• Use of radiocontrast media within 7 days of study drug initiation (other than the small amount of IV contrast that will be needed to place intrarenal catheter to the level of the renal artery)

• Use of nephrotoxic drugs such as aminoglycosides or cisplatinum within 7 days of study initiation

• Use of sildenafil or other PDE5 inhibitors within 24 hours of study drug initiation

• Diseases of weak collagen (i.e. Marfans)

• Aortic or renal aneurysm

• Significant calcification in the region of the renal ostia, or any other condition that would, in the opinion of the investigator, increase risk of placement of an intravascular sheath and catheter.

• Known bleeding diathesis

• Solitary kidney or solitary functioning kidney

• Known uncorrected renal artery stenosis greater than 50% in either renal artery.