Sub Acute B-Type Natriuretic Peptide (BNP) Response to Sodium Loading - Full Text View

Sponsors and Collaborators:	Mayo Clinic National Institutes of Health (NIH)
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00818974

Purpose

To define in normal controls, human PSD and PDD the actions of acute SQ BNP on the cardiorenal and humoral function and the integrated response to acute sodium loading

Condition	Intervention	Phase
Heart Failure	Drug: nesiritide (BNP)	Phase I

MedlinePlus related topics: Heart Failure

Drug Information available for: Nesiritide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacokinetics Study
Official Title:	To Define in Human PSD and PDD the Actions of Acute SQ BNP on the Left Ventricle , Renal and Humoral Function and the Integrated Response to Acute Sodium Loading Dose

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

To define in normal control, human PSD and PDD the actions of acute SQ BNP on the left ventricular, renal and humoral function and on the integrated response to acute sodium loading. [ Time Frame: at the end - data analysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To define in human PSD and PDD the actions of chronic administration of SQ BNP on left ventricular, renal and humoral function and on the integrated response [ Time Frame: at the end - data anaylsis ] [ Designated as safety issue: No ]

Enrollment:	58
Study Start Date:	January 2006
Study Completion Date:	December 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
healthy controls- no heart failure: Active Comparator will receive sodium loading dose and both study visits along with intervention	Drug: nesiritide (BNP) 0.005 mcg/kg on one study day , placebo one study day
Systolic ventricular dysfunction: Active Comparator will receive sodium loading dose and intervention both study days	Drug: nesiritide (BNP) 0.005 mcg/kg on one study day , placebo one study day
diastolic dysfunction: Active Comparator will receive sodium loading dose and intervention both study days	Drug: nesiritide (BNP) 0.005 mcg/kg on one study day , placebo one study day

Detailed Description:

In subjects with PSD and PDD, acute SQ BNP administration will result in improvement of renal response to acute sodium loading with a greater increase in urinary sodium excretion, urine flow, glomerular filtration rate, and effective renal plasma flow as compared to placebo. The improvement of renal response in subjects with PSD or PDD will be greater when compared to normal controls.
In subjects with PSD and PDD, acute SQ BNP administration will result in improvement of the humoral response to acute sodium loading with greater suppression of plasma renin activity, plasma angiotensin II, plasma aldosterone and plasma catecholamines as compared to placebo. The improvement of humoral response in subjects with PSD or PDD will be greater when compared to normal controls.
In subjects with PSD and PDD, acute SQ BNP administration will result in an altered cardiac response to acute sodium loading. Specifically, in response to acute sodium loading, subjects receiving BNP will display:

Inclusion PSD EF of less than 40% with no clinical signs or symptoms of CHF PDD EF greater than 50% with gr 2 diastolic disfunction or greater and no signs or symptoms of CHF

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Group1 (Normal Controls) - will consist of 20 subjects with an ejection fraction of greater 50% and normal Doppler diastolic function with no clinical signs or symptoms and history of cardiovascular and renal disease
Group2 (PSD) - will consist of 20 subjects with an ejection fraction of less than 40% with no clinical signs or symptoms of congestive heart failure and a minimal distance on 6-minute walk of > 450 meters
Group 3 (PDD) - will consist of 20 subjects with ejection fraction of greater than 50% with moderate or severe diastolic dysfunction as assessed by Doppler echocardiography, who do not have any signs or symptoms of congestive heart failure (see Core B for classification of diastolic dysfunction) and a minimal distance on 6-minute walk of > 450 meters
MI within 3 months of screening
Unstable angina within 14 days of screening, or any evidence of myocardial ischemia
Significant valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis
Severe congenital heart diseases
Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening
Second or third degree heart block without a permanent cardiac pacemaker
Stroke within 3 months of screening, or other evidence of significantly compromised CNS perfusion
Total bilirubin of > 1.5 mg/dL or other liver enzymes >1.5 times the upper limit of normal
Serum creatinine of > 3.0 mg/dL
Serum sodium of < 125 mEq/dL or > 160 mEq/dL
Serum potassium of < 3.5 mEq/dL or > 5.0 mEq/dL
Serum digoxin level of > 2.0 ng/ml
Systolic pressure of < 85 mmHg
Hemoglobin < 10 gm/dl

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818974

Sponsors and Collaborators

Mayo Clinic

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Horng Chen, MD

Mayo Clinic

More Information

Responsible Party:	Mayo Clinic ( Dr Chen )
Study ID Numbers:	00387621
Study First Received:	January 6, 2009
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00818974
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Natriuretic Peptide, Brain
Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs

Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009