Intra-Renal Infusion of BNP in Enhancing Renal Function in Human CHF With Cardiorenal Syndrome - Full Text View

Sponsors and Collaborators:	Mayo Clinic FlowMedic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00348556

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 measure by GFR and sodium excretion in patients hospitalized with acute CHF and cardiorenal syndrome

Condition	Intervention	Phase
Cardiorenal Syndrome	Drug: Natrecor (Nesiritide)	Phase I

Drug Information available for: Nesiritide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Efficacy of Intra-Renal Infusion of BNP in Enhancing Renal Function in Human CHF With Cardiorenal Syndrome: A Pilot Study

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

To determine the safety and effectiveness of intrarenal BNP infusion in improving renal function in patients with cardiorenal syndrome [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the neurohumoral effects of intrarenal infusion of BNP in patients with cardiorenal syndrome [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Heart Failure patient with cardi-renal syndrome	Drug: Natrecor (Nesiritide) Natrrecor 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.

Detailed Description:

After informed consent has been obtained, patients will fast overnight for the insertion of the FlowMedica Benephit D Infusion System in the St Mary's Hospital Cardiac Catheterization Lab. IV heparin will be started in the Cath Lab as per the weight base nomogram.

After the insertion of the catheter, the patient will be transferred to the Coronary Intensive Care Unit, 4 Mary Brigh, where the nursing staff are familiar with femoral sheaths and catheter and a cardiac Interventional fellow is available 24 hours for management of any potential complications as a result of the femoral sheath. A bedside abdominal x-ray will be done following transfer to confirm the position of the bifurcated catheter. A urinary catheter will be inserted for the collection of urine.

Patients will then receive the priming dose followed by continuous infusion of Iothalmate and PAH which will determine the GFR and renal plasma flow (RPF) (see Assessment of GFR and RPF). Patients will receive Intrarenal infusion of BNP (Nesiritide) 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. GFR and RPF will be assessed at baseline, 6, 12, 18 and 24 hours. Venous Blood will be collected at baseline, 6, 12, 18 and 24 hours for assessment of BNP, creatinine, cGMP, renin, angiotensin II and Aldosterone. Urine samples will be collected at baseline, 6, 12, 18 and 24 hours for assessment of BNP, cGMP and sodium excretion.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 Cockroft-Gault equation of £ 60 mL/min.
Worsening renal function after >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.
Ability to provide informed consent. Exclusion Criteria (Any of the Following) 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 Benephit System 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

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

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lynn K. Harstad 507-284-4838 harstad.lynn@mayo.edu
Principal Investigator: Horng H. Chen, M.D.

Sponsors and Collaborators

Mayo Clinic

FlowMedic

Investigators

Principal Investigator:

Horng H. Chen, M.D.

Mayo Clinic

More Information

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

Responsible Party:	Mayo Foundation ( Dr. Horng Chen )
Study ID Numbers:	05-004007
Study First Received:	June 30, 2006
Last Updated:	January 30, 2008
ClinicalTrials.gov Identifier:	NCT00348556
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Study placed in the following topic categories:

Natriuretic Peptide, Brain

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 14, 2009