Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of Medicine and Dentistry New Jersey Scios, Inc. |
---|---|
Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00505791 |
Heart failure (HF) is a disease that is caused by a reduced heart muscle function. Reduced heart muscle function can occur as a consequence of reduced pumping activity from a weak heart muscle or because of a stiff heart muscle. This study is looking at the effectiveness of Natrecor (nesiritide) in patients that require hospitalization due to worsening heart failure as a result of a stiff or thickened heart muscle. Natrecor is a man-made version of a protein that my body makes on its own and has been approved for the treatment of patients requiring hospital admission for heart failure and have shortness of breath at rest or with minimal activity.
Natrecor has shown to lower the pressures in the heart and decreases the congestion in the lungs. This study is being done to see if the addition of a Natrecor to standard medical therapy for HF will improve symptoms faster or more completely than giving only the standard treatment for CHF.
Condition | Intervention | Phase |
---|---|---|
Heart Failure, Congestive Dyspnea Pulmonary Edema |
Drug: Nesiritide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Double Blind Randomized Placebo Controlled Trial of Natrecor in Patients Hospitalized for Decompensated Heart Failure in the Presence of a Normal Left Ventricular Ejection Fraction |
Estimated Enrollment: | 46 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | August 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marc Klapholz, MD | 973-972-4731 | klapholz@umdnj.edu |
Contact: David Sedaghat, MD | 973-972-4731 | sedaghatd@yahoo.com |
United States, New Jersey | |
University of Medicine and Dentistry of New Jersey/ New Jersey Medical School | |
Newark, New Jersey, United States, 07103 |
Principal Investigator: | Marc Klapholz, MD | University of Medicine and Dentistry of New Jersey/ New Jersey Medical School |
Study ID Numbers: | IRB# 0120050150, IRB# 0120050150, IND 43,998 serial number:0329 |
Study First Received: | July 19, 2007 |
Last Updated: | July 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00505791 History of Changes |
Health Authority: | United States: Institutional Review Board |
Acute decompensated heart failure Normal left ventricular ejection fraction Vasodilator therapy |
Natriuretic Peptide, Brain Vasodilator Agents Heart Failure Heart Diseases Pulmonary Edema |
Respiratory Tract Diseases Lung Diseases Edema Cardiovascular Agents Dyspnea |
Natriuretic Peptide, Brain Heart Failure Heart Diseases Pulmonary Edema Respiratory Tract Diseases Natriuretic Agents |
Therapeutic Uses Lung Diseases Physiological Effects of Drugs Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |