Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405639
Status:
COMPLETED
Last Update Posted:
2014-03-17
First Post:
2006-11-29
Brief Title:
Human B-type Natriuretic Peptide BNP Nesiritide to Help Heart Kidney and Hormonal Functions in Persons With Lower Heart Pumping Function
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
To Define in Human Preclinical Systolic Dysfunction PSD 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
Status:
COMPLETED
Status Verified Date:
2014-02
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:
The following are done for screening procedures to determine if patients are eligible for this study blood count kidney and liver blood tests Patients will complete a 6-minute walk test Patients will be instructed to follow a no-added-salt diet for 1-3 weeks before the study and for the whole duration of the study Diet instructions will be given to the patient and the patient will collect hisher urine for 24 hours before the active study day Patients will need to avoid strenuous exercise and abstain from smoking alcohol and caffeine for 3 days prior to the study days Patients will remain on their regular medications
Detailed Description:
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 General Clinical Research Center GCRC at St Marys Hospital During the two in-patient stays in the GCRC blood and urine samples will be done to get heart and kidney function as well as a research echo After enrollment the study lasts for twelve weeks There is a one week visit in outpatient setting getting a blood draw and a 6 week visit in outpatient setting to get a blood draw 24 hour urine collection and resupply the study medication There is a one week visit in outpatient setting getting a blood draw and a 6 week visit in outpatient setting to get a blood draw 24 hour urine collection and resupply the study medication
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 |
|---|---|---|---|
| P01HL076611 | NIH | None | None |
| UL1RR024150 | NIH | None | httpsreporternihgovquickSearchUL1RR024150 |