Use of Nesiritide in the Management of Acute Diastolic Heart Failure - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00083772

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 IV

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:

MedlinePlus related topics: Heart Diseases Heart Failure

Drug Information available for: Nesiritide

U.S. FDA Resources

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

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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

Additional Information:

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

Publications:

Krishnaswamy P, Lubien E, Clopton P, Koon J, Kazanegra R, Wanner E, Gardetto N, Garcia A, DeMaria A, Maisel AS. Utility of B-natriuretic peptide levels in identifying patients with left ventricular systolic or diastolic dysfunction. Am J Med. 2001 Sep;111(4):274-9.

Cheng V, Kazanagra R, Garcia A, Lenert L, Krishnaswamy P, Gardetto N, Clopton P, Maisel A. A rapid bedside test for B-type peptide predicts treatment outcomes in patients admitted for decompensated heart failure: a pilot study. J Am Coll Cardiol. 2001 Feb;37(2):386-91.

Zile MR, Gaasch WH, Carroll JD, Feldman MD, Aurigemma GP, Schaer GL, Ghali JK, Liebson PR. Heart failure with a normal ejection fraction: is measurement of diastolic function necessary to make the diagnosis of diastolic heart failure? Circulation. 2001 Aug 14;104(7):779-82.

Mills RM, Hobbs RE, Young JB. "BNP" for heart failure: role of nesiritide in cardiovascular therapeutics. Congest Heart Fail. 2002 Sep-Oct;8(5):270-3. Review.

Publication Committee for the VMAC Investigators (Vasodilatation in the Management of Acute CHF). Intravenous nesiritide vs nitroglycerin for treatment of decompensated congestive heart failure: a randomized controlled trial. JAMA. 2002 Mar 27;287(12):1531-40. Erratum in: JAMA 2002 Aug 7;288(5):577.

Responsible Party:	Jean-Bernard Durand, MD/Associate Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00083772 History of Changes
Other Study ID Numbers:	2003-0782
Study First Received:	June 2, 2004
Last Updated:	March 11, 2009
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

Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012