Human BNP (Nesiritide) to Help Heart, Kidney, and Hormonal Functions in Persons With Lower Heart Pumping Function
| Status: | Archived |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
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
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 his/her 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. Please read the detailed description for more information.
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 at the Charlton Building 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.
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