Status:
TERMINATED
Renal Effects of Intrarenal Nesiritide
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 a...
Detailed Description
We will perform an open-label, parallel arm, controlled study of intrarenal nesiritide in 26 patients hospitalized with CHF. Patients will be admitted for CHF exacerbation and randomly but equally div...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00270829
Start Date
December 1 2005
End Date
January 1 2007
Last Update
December 23 2019
Active Locations (1)
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1
University of Maryland
Baltimore, Maryland, United States, 21201