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Study of Nesiritide in Diastolic Heart Failure.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00309868
First Posted: April 3, 2006
Last Update Posted: March 26, 2014
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.
Collaborator:
Scios, Inc.
Information provided by (Responsible Party):
Marc Semigran, Massachusetts General Hospital
  Purpose
We hypothesize that nesiritide will have favorable effect in decreasing heart filling pressures and echocardiogram studies.

Condition Intervention Phase
Diastolic Heart Failure Drug: neseritide Phase 1 Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Marc Semigran, Massachusetts General Hospital:

Estimated Enrollment: 20
Study Start Date: December 2002
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: neseritide
    Other Name: BNP
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.

  Eligibility

Information from the National Library of Medicine

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

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.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00309868


Sponsors and Collaborators
Massachusetts General Hospital
Scios, Inc.
Investigators
Principal Investigator: Marc J S, MD Massachusetts General Hospital
  More Information

Responsible Party: Marc Semigran, Medical Director , Heart Failure and Cardiac Transplantation, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00309868     History of Changes
Other Study ID Numbers: 2002-p-001736
First Submitted: March 30, 2006
First Posted: April 3, 2006
Last Update Posted: March 26, 2014
Last Verified: March 2014

Keywords provided by Marc Semigran, Massachusetts General Hospital:
heart catheterization
echocardiogram
nesiritide

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs