Human Brain Natriuretic Peptide (BNP) (or Nesiritide) to Help Heart, Kidney and Humoral Function.
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|ClinicalTrials.gov Identifier: NCT00405548|
Recruitment Status : Completed
First Posted : November 30, 2006
Results First Posted : May 9, 2014
Last Update Posted : July 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Left Ventricular Diastolic Dysfunction||Drug: BNP (nesiritide) Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|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|
Active Comparator: BNP (nesiritide)
BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
Drug: BNP (nesiritide)
Placebo Comparator: Placebo
Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
- 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).
- 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.
- 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.
- 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.
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
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Horng H. Chen, M.D.||Mayo Clinic|