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Double Blind Randomized Placebo Controlled Trial of Natrecor in Acute Decompensated Heart Failure With Normal EF
This study is not yet open for participant recruitment.
Verified by University of Medicine and Dentistry New Jersey, July 2007
First Received: July 19, 2007   Last Updated: July 24, 2007   History of Changes
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
  Purpose

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

Resource links provided by NLM:


Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • The primary endpoint of this study will be an absolute reduction in brain natriuretic peptide (BNP) three hours after discontinuation of the study drug. [ Time Frame: Three hours after discontinuation of the study drug ]

Secondary Outcome Measures:
  • All cause in-hospital mortality [ Time Frame: 30 days post-randomization ]
  • Physician and patient global score at 24 hours [ Time Frame: 30 days post-randomization ]
  • Twenty-four hour urine output after start of study drug infusion [ Time Frame: 30 days post-randomization ]
  • Weight change at 24 hours after start of study drug infusion [ Time Frame: 30 days post-randomization ]

Estimated Enrollment: 46
Study Start Date: August 2007
Estimated Study Completion Date: August 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients greater than 18 years of age
  • Admission to the ED for congestive heart failure requiring IV diuretics and hospitalization
  • Chest X-ray evidence of pulmonary congestion (pleural effusion will not suffice).
  • Physical evidence of volume overload i.e. rales or edema at time of randomization.
  • Normal left ventricular ejection fraction (EF >50%) on echocardiography after presentation to the ER.
  • Patients must be able to provide informed consent.

Exclusion Criteria:

  • Acute coronary syndrome with evidence of active ischemia as evident by acute ST segment or T wave changes or initial cardiac enzymes that demonstrate myocardial necrosis or requiring IV nitroglycerin for treatment.
  • Hemodynamically unstable patients that require invasive monitoring or mechanical ventilation.
  • Cardiogenic shock, volume depletion, or any other clinical condition that would contraindicate the administration of IV diuretics, ACE inhibitors, or an IV agent with potent vasodilating properties.
  • Systolic blood pressure >220mmHg or diastolic blood pressure >110mHg.
  • Systolic blood pressure consistently <90 mmHg.
  • Tachyarrhythmia (HR>120).
  • Bradyarrythmia (HR < 50).
  • Myocarditis.
  • Hypertrophic obstructive cardiomyopathy.
  • Restrictive or infiltrative cardiomyopathy including amyloid or sarcoid.
  • Constrictive cardiomyopathy.
  • Primary right sided heart failure or severe pulmonary hypertension (pulmonary artery pressure > 60mmHg).
  • Significant aortic or mitral valve stenosis (Aortic Valve Area < 1.0cm2, Mitral Valve Area < 1.5 cm2
  • Aortic or mitral insufficiency ≥ 3+.
  • Malfunctioning artificial valve.
  • Uncorrected congenital heart disease.
  • Concomitant administration of IV Dobutamine, or other IV vasoactive medications from 2 hours before the start of the study drug until 3 hours after the start of the study drug;
  • Administration of IV Nitroglycerin or IV Milrinone.
  • Concomitant administration of oral ACE inhibitor medication from 2 hours before the start of the study drug until 30 minutes after the start of the study drug.
  • Severe COPD/Asthma as assessed by clinical criteria, prior PFT's or if the patient requires chronic oral steroid treatment.
  • Other significant pulmonary disease that causes significant SOB/DOE i.e. pneumoconiosis etc.
  • Patients with creatinine > 3.0 mg/dl.
  • Patients with a serum potassium level < 3.5, >5.5 mmol/l.
  • Anemia with a Hob < 9 g/dl.
  • Acute neurological event.
  • Known allergic reaction or contraindication to Natrecor or furosemide.
  • Pregnancy or suspected pregnancy.
  • Patients with a history of ETOH abuse or other illicit drug abuse.
  • Patients with active liver, hematologic, gastrointestinal, immunologic, endocrine, metabolic, central nervous system or other medical condition disease which in the opinion of the investigator may adversely effect the safety and efficacy of the study drug or the lifespan of the patient.
  • Therapy with an investigational drug.
  • Unwillingness or inability to comply with study requirements including the 30-day follow-up period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505791

Contacts
Contact: Marc Klapholz, MD 973-972-4731 klapholz@umdnj.edu
Contact: David Sedaghat, MD 973-972-4731 sedaghatd@yahoo.com

Locations
United States, New Jersey
University of Medicine and Dentistry of New Jersey/ New Jersey Medical School
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Scios, Inc.
Investigators
Principal Investigator: Marc Klapholz, MD University of Medicine and Dentistry of New Jersey/ New Jersey Medical School
  More Information

Publications:
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

Keywords provided by University of Medicine and Dentistry New Jersey:
Acute decompensated heart failure
Normal left ventricular ejection fraction
Vasodilator therapy

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Vasodilator Agents
Heart Failure
Heart Diseases
Pulmonary Edema
Respiratory Tract Diseases
Lung Diseases
Edema
Cardiovascular Agents
Dyspnea

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 11, 2009