Ignite Creation Date:
2024-05-06 @ 12:19 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01544998
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2012-01-24
Brief Title:
Tadalafil and Nesiritide as Therapy in Pre-clinical Heart Failure
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
To Define the Role of PDEV in Mediating the Decreased GFR and Attenuated Renal Sodium and cGMP Excretory Response to Acute Saline Volume Expansion in PSD and PDD With Renal Dysfunction
Status:
COMPLETED
Status Verified Date:
2018-02
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:
None
Brief Summary:
This study is being done to determine the effects of subcutaneous under the skin injection of human B-type natriuretic factor BNP Natrecor nesiritide a hormone produced by the heart in combination with Tadalafil on
The pumping function of the heart
Kidney function
Hormonal function levels of different hormones in your blood in persons with lower pumping function of their heart
The pumping function of the heart
Kidney function
Hormonal function levels of different hormones in your blood in persons with lower pumping function of their heart
Detailed Description:
In the American Heart AssociationAmerican College of Cardiology classification of heart failure HF stage B is defined as patients with abnormal heart structurefunction systolic or diastolic dysfunction without symptoms This concept of preclinical HF is based on the fact that abnormal heart structurefunction can be detected by complementary methods before the development of symptoms Patients with those abnormalities may progress to heart failure and are at increased risk of adverse cardiac events Preclinical systolic dysfunction PSD is the initial compensated phase of left ventricular systolic dysfunction without symptoms of HF We have established that diastolic dysfunction is common in the general population being present in approximately 25 of the population over age 45 the majority of whom are asymptomatic ie preclinical diastolic dysfunction PDD Cyclic guanosine monophosphate cGMP is the second messenger of the natriuretic peptide system NPS and the nitric oxide system NO and plays an important role in the preservation of myocardial vascular and renal function Hence disruption of this signal transduction process may contribute to the development of cardiorenal dysfunction Type V phosphodiesterase PDEV metabolizes cGMP and is abundant in the kidney vasculature and has been recently reported in the heart We and others have demonstrated that renal PDEV is up-regulated in experimental HF and may lead to the attenuation of renal cGMP generation in response to both endogenous and exogenous BNP thus serving as a mechanism for renal resistance to BNP Furthermore in experimental overt HF 10 days of PDEV inhibition treatment resulted in reduction of left ventricular LV mass increased LV fractional shortening and cardiac output but did not improve renal function However chronic PDEV inhibition did enhance the renal actions of exogenous BNP specifically improving glomerular filtration rate GFR and renal cGMP generation PDEV inhibitors are FDA approved for erectile dysfunction and pulmonary hypertension
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 5P01HL076611 | NIH | None | httpsreporternihgovquickSearch5P01HL076611 |
| UL1RR024150 | NIH | None | None |