Status:
TERMINATED
Use of Nesiritide in the Management of Acute Diastolic Heart Failure
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Heart Failure
Cardiovascular Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief 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 admitte...
Detailed Description
Patients with diastolic heart failure often have high pressure in their heart and lungs and many symptoms such as shortness of breath, low energy, fluid retention, and fatigue. Decreasing the pressure...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
Key Trial Info
Start Date :
May 17 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2006
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00083772
Start Date
May 17 2004
End Date
April 24 2006
Last Update
November 7 2018
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