Double Blind Randomized Placebo Controlled Trial of Natrecor in Acute Decompensated Heart Failure With Normal EF

Withdrawn before enrolling · Phase 4

Conditions studied: Heart Failure, Congestive, Dyspnea, Pulmonary Edema

In brief

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.

Key facts

Study ID

NCT00505791

Run by

University of Medicine and Dentistry of New Jersey

People needed

0

Starts

2007-08-01

Expected to finish

2008-08-01

Last updated by the study team

2015-11-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Medicine and Dentistry of New Jersey/ New Jersey Medical School — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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