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| ID | Type | Description | Link |
|---|---|---|---|
| P01HL076611 | U.S. NIH Grant/Contract | View source | |
| UL1RR024150 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Scios, Inc. | INDUSTRY |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Center for Research Resources (NCRR) |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BNP (nesiritide) | Active Comparator | BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks |
|
| Placebo | Placebo Comparator | Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNP (nesiritide) | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urinary Sodium Excretion in Response to Saline Load | Renal (or kidney) function was measured by the sodium or salt in the urine, following administration of a pre-specified amount of saline (salt). | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urinary Flow in Response to Saline Load | Urinary flow is a measure of renal (or kidney) function and was measured in milliliters per minute. | Baseline, 12 weeks |
| Change in Glomerular Filtration Rate (GFR) in Response to Saline Load |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Horng H. Chen, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26874387 | Derived | Wan SH, McKie PM, Schirger JA, Slusser JP, Hodge DO, Redfield MM, Burnett JC Jr, Chen HH. Chronic Peptide Therapy With B-Type Natriuretic Peptide in Patients With Pre-Clinical Diastolic Dysfunction (Stage B Heart Failure). JACC Heart Fail. 2016 Jul;4(7):539-547. doi: 10.1016/j.jchf.2015.12.014. Epub 2016 Feb 10. |
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49 participants signed written informed consent to enroll in the study. Of these 8 were withdrawn prior to randomization for varying reasons.
Participants were recruited at the Mayo Clinic in Rochester, Minnesota.
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| ID | Title | Description |
|---|---|---|
| FG000 | BNP (Nesiritide) | Brain Natriuretic Peptide (BNP) 10 micrograms/Kg twice per day given subcutaneously for 12 weeks |
| FG001 | Placebo | Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BNP (Nesiritide) | BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks |
| BG001 | Placebo | Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change in Urinary Flow in Response to Saline Load | Urinary flow is a measure of renal (or kidney) function and was measured in milliliters per minute. | Posted | Mean | Standard Deviation | ml/minute | Baseline, 12 weeks |
|
Baseline to 12 weeks during study with a 6 month follow-up telephone call to subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BNP (Nesiritide) | BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Horng H. Chen | Mayo Clinic | 507-538-2354 | chen.horng@mayo.edu |
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| ID | Term |
|---|---|
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D020097 | Natriuretic Peptide, Brain |
| ID | Term |
|---|---|
| D045265 | Natriuretic Peptides |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| NIH |
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| Placebo |
| Drug |
|
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.
| Baseline, 12 weeks |
| Left Ventricular (LV) Filling Pressure | 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. | Baseline, 12 weeks |
| Unable to self-administer shots |
|
| Venous access failed during study day |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Change in Glomerular Filtration Rate (GFR) in Response to Saline Load | 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. | Posted | Mean | Standard Deviation | ml/min/1.73 m^2 body surface area | Baseline, 12 weeks |
|
|
|
|
| Primary | Change in Urinary Sodium Excretion in Response to Saline Load | Renal (or kidney) function was measured by the sodium or salt in the urine, following administration of a pre-specified amount of saline (salt). | Posted | Mean | Standard Deviation | mEq/minute | Baseline, 12 weeks |
|
|
|
|
| Secondary | Left Ventricular (LV) Filling Pressure | 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. | Posted | Mean | Standard Deviation | E/e' | Baseline, 12 weeks |
|
|
|
|
| 0 |
| 24 |
| 5 |
| 24 |
| EG001 | Placebo | Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator) | 0 | 12 | 3 | 12 |
| Heart Failure symptoms | Cardiac disorders | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypotension | Cardiac disorders | Systematic Assessment |
|
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| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| t-test, 2 sided |
A p-value of less 0.05 was considered to be statistically significant. |
| 0.43 |
| 95 |
| No |
| Superiority or Other |