Study of Nesiritide in Diastolic Heart Failure.

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

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Key information

Conditions

Diastolic Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Diastolic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neseritide

Drug

Other names: BNP

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

Scios, Inc.

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: Apr 3, 2006
Registry last updated: Mar 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed