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

This study has been terminated.
(Company providing catheter bought out, funding and supplies terminated)
Sponsor:
Collaborator:
FlowMedica, Inc.
Information provided by (Responsible Party):
Horng Chen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00348556
First received: June 30, 2006
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Cardiorenal Syndrome
Drug: Nesiritide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in Glomerular Filtration Rate (GFR) at 24 Hours [ Time Frame: baseline, 24 hours after start of infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Urinary Sodium Excretion at 24 Hours [ Time Frame: baseline, 24 hours after start of infusion ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: December 2005
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348556

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

Additional Information:
No publications provided

Responsible Party: Horng Chen, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00348556     History of Changes
Other Study ID Numbers: 05-004007
Study First Received: June 30, 2006
Results First Received: September 14, 2012
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014