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Human Brain Natriuretic Peptide (BNP) (or Nesiritide) to Help Heart, Kidney and Humoral Function.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00405548
Recruitment Status : Completed
First Posted : November 30, 2006
Results First Posted : May 9, 2014
Last Update Posted : July 1, 2015
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Scios, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Horng Chen, Mayo Clinic

Brief Summary:
The purpose of this research study is to evaluate the effects of cardiac hormone replacement with SQ (subcutaneous or under the skin) injection of BNP (brain natriuretic peptide, 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 or disease Intervention/treatment Phase
Left Ventricular Diastolic Dysfunction Drug: BNP (nesiritide) Drug: Placebo Phase 1 Phase 2

Detailed Description:
Prior to initiation of the study, subjects will be stabilized for at least one week on a no added salt diet (120 milliequivalent (mEq) Na/Day) which will be maintained during the study. 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 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 Clinical Research Unit at St. Marys Hospital. During the two overnight stays, blood and urine samples will be done to get heart and kidney function as well as a research echocardiogram. An acute saline load (0.9% normal saline 1.25 ml/kg/min for 1 hour) will be given and blood and urine samples collected After enrollment, the study lasts for twelve weeks. It is planned to treat 2 subjects with active drug per each placebo subject to improved the precision of between group comparison.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: To Define in Human Preclinical Diastolic Dysfunction (PDD) the Actions of Chronic Administration of Subcutaneous (SQ) BNP on the Left Ventricular, Renal and Humoral Function and on the Integrated Response to Acute Sodium Loading
Study Start Date : March 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Nesiritide

Arm Intervention/treatment
Active Comparator: BNP (nesiritide)
BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
Drug: BNP (nesiritide)
Other Names:
  • natrecor
  • nesiritide

Placebo Comparator: Placebo
Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
Drug: Placebo



Primary Outcome Measures :
  1. Change in Urinary Sodium Excretion in Response to Saline Load [ Time Frame: Baseline, 12 weeks ]
    Renal (or kidney) function was measured by the sodium or salt in the urine, following administration of a pre-specified amount of saline (salt).


Secondary Outcome Measures :
  1. Change in Urinary Flow in Response to Saline Load [ Time Frame: Baseline, 12 weeks ]
    Urinary flow is a measure of renal (or kidney) function and was measured in milliliters per minute.

  2. Change in Glomerular Filtration Rate (GFR) in Response to Saline Load [ Time Frame: Baseline, 12 weeks ]
    Renal or kidney function was 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/ml/1.73 m^2 of body surface area is considered to be impaired kidney function.

  3. Left Ventricular (LV) Filling Pressure [ Time Frame: Baseline, 12 weeks ]
    LV diastolic function as measured by Doppler echocardiography. E/e' is the ratio of the mitral inflow velocity (E) to the mitral annulus tissue Doppler velocity (e'). A decrease in the ratio indicates a lower filling pressure and improved LV diastolic function.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

  • Myocardial Infarction (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 central nervous system (CNS) perfusion
  • Total bilirubin of > 1.5 mg/dL or other liver enzymes > 1.5 times the upper limit of normal (mg/dL = milligrams per deciliter)
  • Serum creatinine of > 3.0 mg/dL
  • Serum sodium of < 125 mEq/dL or > 160 mEq/dL (milliequivalents per deciliter)
  • Serum potassium of < 3.5 mEq/dL or > 5.0/dL
  • Serum digoxin level of > 2.0 ng/ml (nanograms per milliliter)
  • Systolic pressure of < 85 mm Hg (millimeters of mercury)
  • Hemoglobin < 10 gm/dl (grams per deciliter)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405548


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institutes of Health (NIH)
Scios, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
Investigators
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Principal Investigator: Horng H. Chen, M.D. Mayo Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Horng Chen, Dr Horng H Chen, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00405548    
Other Study ID Numbers: 05-004190
P01HL076611 ( U.S. NIH Grant/Contract )
UL1RR024150 ( U.S. NIH Grant/Contract )
First Posted: November 30, 2006    Key Record Dates
Results First Posted: May 9, 2014
Last Update Posted: July 1, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs