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Study of Nesiritide in Diastolic Heart Failure.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00309868
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : March 26, 2014
Scios, Inc.
Information provided by (Responsible Party):
Marc Semigran, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Diastolic Heart Failure Drug: neseritide Phase 1 Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Nesiritide

Intervention Details:
  • Drug: neseritide
    Other Name: BNP

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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


Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00309868

Sponsors and Collaborators
Massachusetts General Hospital
Scios, Inc.
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Principal Investigator: Marc J S, MD Massachusetts General Hospital
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Responsible Party: Marc Semigran, Medical Director , Heart Failure and Cardiac Transplantation, Massachusetts General Hospital Identifier: NCT00309868    
Other Study ID Numbers: 2002-p-001736
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014
Keywords provided by Marc Semigran, Massachusetts General Hospital:
heart catheterization
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases