Study of Nesiritide in Diastolic Heart Failure.

This study has been completed.
Sponsor:
Collaborator:
Scios, Inc.
Information provided by (Responsible Party):
Marc Semigran, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00309868
First received: March 30, 2006
Last updated: March 24, 2014
Last verified: March 2014

March 30, 2006
March 24, 2014
December 2002
December 2003   (final data collection date for primary outcome measure)
Not Provided
  • Patients will have continuous blood pressure, heart rate and heart pressure monitoring.
  • Patients will undergo echocardiogram at baseline and after 24 hours of nesiritide infusion.
Complete list of historical versions of study NCT00309868 on ClinicalTrials.gov Archive Site
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Study of Nesiritide in Diastolic Heart Failure.
A Study of the Acute Hemodynamic and Myocardial Effects of Nesiritide in Diastolic Heart Failure.

We hypothesize that nesiritide will have favorable effect in decreasing heart filling pressures and echocardiogram studies.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diastolic Heart Failure
Drug: neseritide
Other Name: BNP
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2003
December 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

Elevated heart filling pressure. Ejection fraction >45%. Blood pressure >90. Physician feels that the patient needs intravenous medication for heart failure.

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Exclusion Criteria:

Patients receiving intravenous medication. Patients with significant heart disease or who are unstable. Patients with kidney failure or severe heart valve disease.

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Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00309868
2002-p-001736
Not Provided
Marc Semigran, Massachusetts General Hospital
Massachusetts General Hospital
Scios, Inc.
Principal Investigator: Marc J S, MD Massachusetts General Hospital
Massachusetts General Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP