Use of Nesiritide in the Management of Acute Diastolic Heart Failure
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|ClinicalTrials.gov Identifier: NCT00083772|
Recruitment Status : Terminated
First Posted : June 3, 2004
Last Update Posted : November 7, 2018
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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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Cardiovascular Disease Acute Heart Failure Diastolic Heart Failure Congestive Heart Failure Heart Disease||Drug: Nesiritide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Nesiritide in the Management of Acute Diastolic Heart Failure|
|Actual Study Start Date :||May 17, 2004|
|Actual Primary Completion Date :||April 24, 2006|
|Actual Study Completion Date :||April 24, 2006|
Initial dose by vein of 2 mcg/kg then infusion by vein of 0.01 mcg/kg/min continuously for 48 hours.
Other Name: Natrecor
- Effectiveness of nesiritide in improving symptoms, including pressure in heart and lungs, related to diastolic heart failure (condition where heart muscle is stiff and not able to relax completely, causing the pressures in heart to increase). [ Time Frame: 2 Years ]
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|Ages Eligible for Study:||18 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083772
|Study Chair:||Jean-Bernard Durand, MD||UT MD Anderson Cancer Center|
|Responsible Party:||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
|First Posted:||June 3, 2004 Key Record Dates|
|Last Update Posted:||November 7, 2018|
|Last Verified:||November 2018|
Diastolic heart failure
Congestive heart failure
Left ventricular (LV) diastolic function
Shortness of breath
Heart Failure, Diastolic
Natriuretic Peptide, Brain
Physiological Effects of Drugs