Use of Nesiritide (BNP) in Kidney Function in Patients With Congestive Heart Failure (CHF) and Kidney Failure

NCT ID: NCT00348556

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2010-03-31

Brief Summary

The objective of this study is to determine the safety and effectiveness of intrarenal administration of brain natriuretic peptide (BNP) in improving renal function as measured by glomerular filtration rate (GFR) and sodium excretion in patients hospitalized with acute congestive heart failure (CHF) and deterioration of kidney function (cardiorenal syndrome).

Conditions

Cardiorenal Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nesiritide

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.

Group Type: EXPERIMENTAL

Nesiritide

Intervention Type: DRUG

Nesiritide 0.005 ug/kg/min IV for 6 hours, then to 0.01 ug/kg/min for 6 hours then to 0.02ug/kg/min for 6 hours then to 0.03 ug/kg/min for the last 6 hours.

Interventions

Nesiritide

Nesiritide 0.005 ug/kg/min IV for 6 hours, then to 0.01 ug/kg/min for 6 hours then to 0.02ug/kg/min for 6 hours then to 0.03 ug/kg/min for the last 6 hours.

Intervention Type: DRUG

Other Intervention Names

Natrecor; brain natriuretic peptide (BNP)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FlowMedica, Inc.

INDUSTRY

Sponsor Role: collaborator

Horng Chen

OTHER

Sponsor Role: lead

Responsible Party

Horng Chen

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Horng H. Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

05-004007

Identifier Type: -

Identifier Source: org_study_id