Use of Nesiritide in the Management of Acute Diastolic Heart Failure

• Status: Terminated
• Trial end date: 2006-04-24
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective is to assess the effect of nesiritide in decreasing left ventricular (LV) filling pressure, defined as pulmonary artery capillary wedge pressure (PCWP) in a group of patients admitted with acute diastolic heart failure.

Secondary objectives include: improvement in symptoms, exercise tolerance, improvement in Doppler diastolic filling parameters in patients with diastolic heart failure.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Natriuretic Peptide, Brain

Criteria

The patient population recruited for this study will include patients being admitted for acute congestive heart failure. Eligible patients include those who have near normal LV systolic function.

Inclusion Criteria:

• Age 18 to 85 years old

• Admitted with acute heart failure determined by: symptoms of fatigue; shortness of breath; edema; physical evidence of volume overload; and/or pulmonary edema by CXR

• LVEF > or = 40% on recent (< or = 1 month) echo or MUGA

• NYHA class III or IV on admission

• Baseline systolic blood pressure > 90 mm Hg

• Baseline BNP level > 100 pg/ml

• Able to sign informed consent and return for follow-up assessments

Exclusion Criteria:

• Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) <90 mm Hg)

• Active infection/sepsis as defined by fever > 101.5 F, currently on IV antibiotics

• Creatinine greater than 3.0 mg/dl

• LV ejection fraction < 40% (must be done within the last 30 days prior to signing consent)

• Significant valvular disease or constrictive cardiomyopathy

• Severe Thrombocytopenia (as defined by platelets less than 20,000) or INR > 1.6

• Hypersensitivity to nesiritide or any of its components.

• Pulmonary capillary wedge pressure (PCWP) <16 mmHg

• If patient is of child-bearing age, a pregnancy test will be performed, and the patient is excluded if pregnancy test is positive.