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Study of Nesiritide in Diastolic Heart Failure.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Scios, Inc.
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00309868
First received: March 30, 2006
Last updated: May 3, 2010
Last verified: May 2010
History of Changes
  Purpose

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


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

Study Type: Interventional
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.

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
Drug Information available for: Nesiritide
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 20
Study Start Date: December 2002
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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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.

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309868

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Scios, Inc.
Investigators
Principal Investigator: Marc J S, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Marc J. Semigran, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00309868     History of Changes
Other Study ID Numbers: 2002-p-001736
Study First Received: March 30, 2006
Last Updated: May 3, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013