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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00348556
Recruitment Status : Terminated (Company providing catheter bought out, funding and supplies terminated)
First Posted : July 4, 2006
Results First Posted : October 17, 2012
Last Update Posted : November 6, 2017
FlowMedica, Inc.
Information provided by (Responsible Party):
Horng Chen, Mayo Clinic

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).

Condition or disease Intervention/treatment Phase
Cardiorenal Syndrome Drug: Nesiritide Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Intra-renal Infusion of BNP in Enhancing Renal Function in Human CHF With Cardiorenal Syndrome: A Pilot Study
Study Start Date : December 2005
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Nesiritide

Arm Intervention/treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Natrecor
  • brain natriuretic peptide (BNP)

Primary Outcome Measures :
  1. Change in Glomerular Filtration Rate (GFR) at 24 Hours [ Time Frame: baseline, 24 hours after start of infusion ]
    Kidney function was to be measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/min/1.73 m^2 of body surface area is considered to be impaired kidney function.

Secondary Outcome Measures :
  1. Change in Urinary Sodium Excretion at 24 Hours [ Time Frame: baseline, 24 hours after start of infusion ]
    The fractional excretion of sodium (FENa) measures the percent of filtered sodium that is excreted in the urine. This calculation is widely used to help differentiate prerenal disease (decreased renal perfusion) from acute tubular necrosis (ATN) as the cause of acute kidney injury (AKI, formerly called acute renal failure).

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00348556

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Horng Chen
FlowMedica, Inc.
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Principal Investigator: Horng H. Chen, M.D. Mayo Clinic

Additional Information:
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Responsible Party: Horng Chen, MD, Mayo Clinic Identifier: NCT00348556     History of Changes
Other Study ID Numbers: 05-004007
First Posted: July 4, 2006    Key Record Dates
Results First Posted: October 17, 2012
Last Update Posted: November 6, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Cardio-Renal Syndrome
Heart Failure
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs