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

Primary Purpose

Cardiorenal Syndrome

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nesiritide
Sponsored by
Horng Chen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiorenal Syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nesiritide

Arm 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.

Outcomes

Primary Outcome Measures

Change in Glomerular Filtration Rate (GFR) at 24 Hours
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

Change in Urinary Sodium Excretion at 24 Hours
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).

Full Information

First Posted
June 30, 2006
Last Updated
October 3, 2017
Sponsor
Horng Chen
Collaborators
FlowMedica, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00348556
Brief Title
Use of Nesiritide (BNP) in Kidney Function in Patients With Congestive Heart Failure (CHF) and Kidney Failure
Official Title
Efficacy of Intra-renal Infusion of BNP in Enhancing Renal Function in Human CHF With Cardiorenal Syndrome: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Company providing catheter bought out, funding and supplies terminated
Study Start Date
December 2005 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Horng Chen
Collaborators
FlowMedica, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiorenal Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nesiritide
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Nesiritide
Other Intervention Name(s)
Natrecor, brain natriuretic peptide (BNP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Glomerular Filtration Rate (GFR) at 24 Hours
Description
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.
Time Frame
baseline, 24 hours after start of infusion
Secondary Outcome Measure Information:
Title
Change in Urinary Sodium Excretion at 24 Hours
Description
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).
Time Frame
baseline, 24 hours after start of infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horng H. Chen, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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