At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Nesiritide and Placebo for Heart Failure and Asymptomatic Systolic Dysfunction. Completed, enrolled 37 participants across 1 site.
Detailed 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 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.
Study Details
Timeline
Interventions
Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is \>90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
Normal saline will be used for placebo.