Clinical trial NCT00348556: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Cardiorenal Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: FlowMedica, Inc.
First posted: 2006-07-04
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change in Glomerular Filtration Rate (GFR) at 24 Hours
timeFrame: baseline, 24 hours after start of infusion
Secondary outcomes:
measure: Change in Urinary Sodium Excretion at 24 Hours
timeFrame: baseline, 24 hours after start of infusion
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Horng H. Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: