Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387621
Status:
COMPLETED
Last Update Posted:
2012-05-17
First Post:
2006-10-12
Brief Title:
Natriuretic Peptide System as Therapy in Human Preclinical Left Ventricle Dysfunction
Sponsor:
Horng Chen
Organization:
Mayo Clinic
Study Overview
Official Title:
To Define in Normal Controls Human Preclinical Systolic Dysfunction PSD and Preclinical Diastolic Dysfunction PDD the Actions of Acute Subcutaneous Nesiritide BNP on the Cardiorenal and Humoral Function and the Integrated Response to Acute Sodium Loading
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPG1
Brief Summary:
In congestive heart failure cardiac output is low blood pressure is high and the body becomes congested with fluid In normal people when there is high blood pressure the heart muscle cells secrete a hormone that excretes sodium and water in the urine reducing blood pressure The action of this hormone is called the natriuretic response The purpose of this study is to determine if nesiritide can improve an impaired natriuretic response in subjects with asymptomatic systolic heart failure or asymptomatic diastolic heart failure
Detailed Description:
The American Heart Association and the American College of Cardiology define stage B heart failure HF as asymptomatic subjects with abnormal heart structurefunction With the advancement of cardiac imaging and biomarkers abnormal heart structure and function can be detected before the development of symptoms Stage B HF can represent either diastolic or systolic dysfunction and both are at increased risk of adverse cardiac events and development of symptomatic HF
The broad objective of this study is to define the integrated cardiorenal response to acute volume expansion VE in humans with presystolic dysfunction PSD prediastolic dysfunction PDD and normal cardiac function We hypothesized that there is an impaired cardiorenal endocrine response to acute VE in PSD and PDD which is characterized by the lack of appropriate activation of urinary cGMP and urinary sodium excretion Further we hypothesized that PSD PDD and normal control subjects would respond similarly to exogenous administration B-type natriuretic peptide BNP
The natriuretic peptides NPs are a family of structurally similar but genetically distinct peptides with vasodilating natriuretic renin inhibiting and lusitropic properties Acute peptide therapy with brain natriuretic peptide BNP infusion has recently been approved by the FDA as a therapeutic strategy for the treatment of acute human decompensated congestive HF We will determine the effects of acute subcutaneous BNP or placebo administration on the integrated cardiorenal and humoral response to acute sodium load sodium chloride 09 025 mlkgmin for 1 hour in three groups of subjects Group 1 normal controls Group 2 with PSD and Group 3 with PDD Doppler echocardiography and tonometry will be used to measure cardiac and vascular function before and during the sodium load Renal function studies will assess sodium excretion renal plasma flow and glomerular filtration rate at baseline during and after the sodium load Blood will be drawn for humoral analysis including catecholamines renin aldosterone angiotensin II atrial natriuretic peptide ANP BNP and cyclic guanosine monophosphate cGMP at baseline during and after the sodium load
The broad objective of this study is to define the integrated cardiorenal response to acute volume expansion VE in humans with presystolic dysfunction PSD prediastolic dysfunction PDD and normal cardiac function We hypothesized that there is an impaired cardiorenal endocrine response to acute VE in PSD and PDD which is characterized by the lack of appropriate activation of urinary cGMP and urinary sodium excretion Further we hypothesized that PSD PDD and normal control subjects would respond similarly to exogenous administration B-type natriuretic peptide BNP
The natriuretic peptides NPs are a family of structurally similar but genetically distinct peptides with vasodilating natriuretic renin inhibiting and lusitropic properties Acute peptide therapy with brain natriuretic peptide BNP infusion has recently been approved by the FDA as a therapeutic strategy for the treatment of acute human decompensated congestive HF We will determine the effects of acute subcutaneous BNP or placebo administration on the integrated cardiorenal and humoral response to acute sodium load sodium chloride 09 025 mlkgmin for 1 hour in three groups of subjects Group 1 normal controls Group 2 with PSD and Group 3 with PDD Doppler echocardiography and tonometry will be used to measure cardiac and vascular function before and during the sodium load Renal function studies will assess sodium excretion renal plasma flow and glomerular filtration rate at baseline during and after the sodium load Blood will be drawn for humoral analysis including catecholamines renin aldosterone angiotensin II atrial natriuretic peptide ANP BNP and cyclic guanosine monophosphate cGMP at baseline during and after the sodium load
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1RR024150 | NIH | None | httpsreporternihgovquickSearchUL1RR024150 |
| P01HL076611 | NIH | None | None |
| R01HL084155 | NIH | None | None |