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Study of Nesiritide in Diastolic Heart Failure.

Primary Purpose

Diastolic Heart Failure

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

neseritide

About this trial

This is an interventional treatment trial for Diastolic Heart Failure focused on measuring heart catheterization, echocardiogram, nesiritide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00309868

First Posted

March 30, 2006

Last Updated

March 24, 2014

Sponsor

Massachusetts General Hospital

Collaborators

Scios, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00309868

Brief Title

Study of Nesiritide in Diastolic Heart Failure.

Official Title

A Study of the Acute Hemodynamic and Myocardial Effects of Nesiritide in Diastolic Heart Failure.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

December 2002 (undefined)

Primary Completion Date

December 2003 (Actual)

Study Completion Date

December 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Scios, Inc.

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diastolic Heart Failure

Keywords

heart catheterization, echocardiogram, nesiritide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

neseritide

Other Intervention Name(s)

BNP

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marc J S, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Study of Nesiritide in Diastolic Heart Failure.

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