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Use of Nesiritide in the Management of Acute Diastolic Heart Failure
This study has been terminated.
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00083772
  Purpose

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


Condition Intervention Phase
Heart Failure
Cardiovascular Disease
Acute Heart Failure
Diastolic Heart Failure
Congestive Heart Failure
Heart Disease
Drug: Nesiritide (Natrecor)
Phase IV

MedlinePlus related topics: Heart Diseases Heart Failure
Drug Information available for: Nesiritide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: The Use of Nesiritide in the Management of Acute Diastolic Heart Failure

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment: 20
Study Start Date: May 2004
Estimated Study Completion Date: April 2005
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083772

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Jean-Bernard Durand, MD UT MD Anderson Cancer Center
  More Information

drug information  This link exits the ClinicalTrials.gov site
MD Anderson Cancer Center, Department of Cardiology  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 2003-0782
Study First Received: June 2, 2004
Last Updated: May 5, 2006
ClinicalTrials.gov Identifier: NCT00083772  
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
heart failure
diastolic heart failure
congestive heart failure
Nesiritide
Natrecor
left ventricular (LV) diastolic function
fatigue
shortness of breath
edema
heart disease

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Heart Failure, Diastolic
Heart Failure
Fatigue
Heart Diseases
Edema
Dyspnea

Additional relevant MeSH terms:
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009