Chronic Administration of Subcutaneous Brain Natriuretic Peptide (SQ BNP) on the Left Ventricular, Renal and Humoral Function and on the Integrated Response to Acute Sodium Loading - Full Text View

Sponsors and Collaborators:	Mayo Clinic National Institutes of Health (NIH) Scios, Inc.
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00405548

Purpose

The purpose of this research study is to evaluate the effects of cardiac hormone replacement with SQ (under the skin) injection of BNP (a hormone produced by the heart) on the pumping ability of the heart, kidney function and levels of different hormones in the blood in response to an intravenous salt solution.

Condition	Intervention	Phase
Heart Failure	Drug: BNP (natrecor)	Phase I Phase II

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	To Define in Human Preclinical Diastolic Dysfunction (PDD) the Actions of Chronic Administration of SQ BNP on the Left Ventricular, Renal and Humoral Function and on the Integrated Response to Acute Sodium Loading - Protocol III

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Nesiritide

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

To define in human PDD, the actions of chronic administration of SQ BNP on cardiovascular, renal and humoral function and the integrated response to acute sodium loading [ Time Frame: 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Chronic peptide therapy with SQ BNP in subjects with PDD will improve renal function with increased sodium excretion, glomerular filtration rate and effective renal plasma flow in response to acute sodium loading as compared to placebo [ Time Frame: 5 ] [ Designated as safety issue: No ]
Chronic peptide therapy with SQ BNP in subjects with PDD will improve humoral function with the suppression of the renin-angiotensin-aldosterone system, endothelin I, cardiotrophin I and catecholamines as compared to placebo [ Time Frame: 5 ] [ Designated as safety issue: No ]
Chronic therapy with SQ BNP in PDD will improve left ventricular diastolic function, filling pressures as compared to placebo evident by, reduction left atrium volume, improved diastolic relaxation, reduction of plasma procollagen [ Time Frame: 5 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	February 2006
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Pre-diastolic	Drug: BNP (natrecor) 33 subjects will be randomized to 10 ug/kg BNP and 17 subjects will be randomized to placebo

Detailed Description:

Participants in this study will be randomized to receive BNP or placebo (an inactive, saline shot). The participant will need to give themselves a shot in their stomach (similar to diabetics giving themselves insulin) twice a day for twelve weeks. The study requires a screening visit at the Charlton Building to determine eligibility and discuss the study. At this visit a blood draw for heart and liver function and a six minute walk will be done. There will also be two other outpatient visits and two inpatient stays, for 48 hours, in the General Clinical Research Center (GCRC) at St. Marys Hospital. During the two stays in the GCRC, blood and urine samples will be done to get heart and kidney function as well as a research echo. After enrollment, the study lasts for twelve weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with ejection fraction of greater than 50% with moderate or severe diastolic dysfunction as assessed by Doppler echocardiography
No signs or symptoms of congestive heart failure and who have not been hospitalized for heart failure

Exclusion criteria:

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/dL
Serum digoxin level of > 2.0 ng/ml
Systolic pressure of < 85 mm Hg
Hemoglobin < 10 gm/dl

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405548

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sherry Benike 507-266-3629 benike.sherry@mayo.edu
Principal Investigator: Horng H. Chen, M.D.

Sponsors and Collaborators

Mayo Clinic

National Institutes of Health (NIH)

Scios, Inc.

Investigators

Principal Investigator:

Horng H. Chen, M.D.

Mayo Clinic

More Information

No publications provided

Responsible Party:	Mayo Foundation ( Dr. Horng Chen )
Study ID Numbers:	05-004190
Study First Received:	November 29, 2006
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00405548 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Natriuretic Peptide, Brain
Heart Failure
Heart Diseases
Cardiovascular Agents

Additional relevant MeSH terms:

Natriuretic Peptide, Brain
Heart Failure
Heart Diseases
Natriuretic Agents
Therapeutic Uses

Physiological Effects of Drugs
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 03, 2009