Study of Nesiritide in Diastolic Heart Failure.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study of the Acute Hemodynamic and Myocardial Effects of Nesiritide in Diastolic Heart Failure.|
|Study Start Date:||December 2002|
|Study Completion Date:||December 2003|
|Primary Completion Date:||December 2003 (Final data collection date for primary outcome measure)|
In previous studies, patients with systolic heart failure were given nesiritide and had reduced heart filling pressures. The FDA has approved nesiritide for these patients.
Between one-third and one-half of patients with heart failure have diastolic heart failure. Few of these patients have been studied while receiving nesiritide.
A study is needed to test nesiritide on this specific type of heart failure.
Patients will undergo a heart catheterization and heart biopsy. Patients will then be transferred to the intensive care unit for monitoring. An echocardiogram will be obtained, followed by an infusion of nesiritide for 24 hours. At the completion of the infusion, a repeat echocardiogram will be obtained.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309868
|Principal Investigator:||Marc J S, MD||Massachusetts General Hospital|