Intervention: Nesiritide
Trial phase: Phase 1 | Phase 2
ATC code: C01DX19
SMILES: CCC(C)C1NC(=O)C(CCCNC(=N)N)NC(=O)C(CC(=O)O)NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C(CCCNC(=N)N)NC(=O)CNC(=O)C(Cc2ccccc2)NC(=O)C(NC(=O)CNC(=O)C(CO)NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C2CCCN2C(=O)C(N)CO)C(C)C)CSSCC(C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CC(C)C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc2c[nH]cn2)C(=O)O)C(C)C)NC(=O)CNC(=O)C(CC(C)C)NC(=O)CNC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
Eligibility criteria:
Inclusion Criteria

Age 18 years and older
Clinical diagnosis of class III-IV CHF requiring hospitalization
Current acute CHF decompensation
Systolic BP > 90 mmHg
Stable cardiac rhythm
Estimated creatinine clearance by the Cockcroft-Gault equation of less than or equal to 60 mL/min.
Worsening renal function after greater than or equal to 24 hours of standard therapy as defined by a plasma creatinine concentration greater than their admission of 0.3 mg/dL and a 10% increase from hospital admission creatinine OR creatinine which remains at 0.3 mg/dL and 10% increase from baseline draw done within 4 weeks of hospitalization
Ability to provide informed consent

Exclusion Criteria

Patients needing emergency coronary revascularization or those who may have rapidly changing cardiac function (i.e., patients with acute myocardial infarction or shock)
Peritoneal or hemodialysis within 90 days or anticipation that dialysis or ultrafiltration of any form will be required during the study period
Systolic blood pressure < 90 mmHg or cardiogenic shock
Requirement of pressors for maintenance of blood pressure
Intra-aortic blood pump use
History of significant uncorrected renal artery stenosis as defined by >50% stenosis
Severe aortic or mitral stenosis or significant LV outflow tract obstruction
Pregnant or nursing women
Prisoners
Contraindication to nesiritide
Contraindication to heparin
Cause of acute renal dysfunction can be reasonably ascribed to factors other than heart failure or its treatment
Inability to have NSAID dose held for up to 30 hours, if being treated with these medications
Ongoing treatment with calcineurin inhibitors (cyclosporine or tacrolimus)
Administration of radiocontrast medium within 7 days of enrollment or anticipated use of such agents during the study (other than the minimal contrast required to place the renal infusion catheter)
Known bleeding diathesis
Known condition that would increase the likelihood of vascular perforation or trauma, dissection such as Marfan's syndrome, cystic medial necrosis, abdominal or thoracoabdominal aortic dissection, mycotic aneurysm, abdominal aneurysm, thoracoabdominal aneurysm, renal artery aneurysm, thoracic aneurysm involving the visceral region of the aorta, and severe calcification in the area of the renal arteries
Solitary kidney or solitary functioning kidney
Iodine allergy