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Use of Nesiritide in the Management of Acute Diastolic Heart Failure

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00083772
First received: June 2, 2004
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Heart Failure
Cardiovascular Disease
Acute Heart Failure
Diastolic Heart Failure
Congestive Heart Failure
Heart Disease
Drug: Nesiritide
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Nesiritide in the Management of Acute Diastolic Heart Failure

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nesiritide
Drug: Nesiritide
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

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00083772     History of Changes
Other Study ID Numbers: 2003-0782
Study First Received: June 2, 2004
Last Updated: July 27, 2012
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

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Heart Failure
Heart Failure, Diastolic
Natriuretic Peptide, Brain
Cardiovascular Agents
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014